Form 3 INF

CIBMTR Center Number: ___ ___ ___ ___ ___ CIBMTR Recipient ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

R

OMB No: 0915-0310

Expiration Date: 12/31/2013

Public Burden Statement: An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this project is 0915-0310. Public reporting burden for this collection of information, in combination with the IDM Form 2004 and HLA Typing Form 2005, is estimated to average 1.5 hours per response, including the time for reviewing instructions, searching existing data sources, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to HRSA Reports Clearance Officer, 5600 Fishers Lane, Room 10-33, Rockville, Maryland, 20857.

Expiration date: 12/31/2013

egistry Use Only

Sequence Number:

Date Received:

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Recipient ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

Date of HCT for which this form is being completed: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

HCT type: (check only one)

 Autologous

 Allogeneic, unrelated

 Allogeneic, related

Product type: (check only one)

 Bone marrow

 PBSC

 Single cord blood unit

 Other product,

Specify:

If more than one type of HCT product is infused, each product type must be analyzed and reported separately.

A series of collections should be considered a single product when they are all from the same donor and use the same collection method and technique (and mobilization, if applicable), even if the collections are performed on different days.

Donor / Cord Blood Unit Identification

1. Specify donor:

 Autologous – Go to question 16

 Autologous cord blood unit – Go to question 5

 NMDP unrelated cord blood unit – Go to question 2

 NMDP unrelated donor – Go to question 3

 Related donor – Go to question 10

 Related cord blood unit – Go to question 5

 Non-NMDP unrelated donor – Go to question 4

 Non-NMDP unrelated cord blood unit – Go to question 5

2. NMDP Cord Blood Unit ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ – Go to question 15

3. NMDP Donor ID: ___ ___ ___ ___ — ___ ___ ___ ___ — ___ – Go to question 15

4. Non-NMDP unrelated donor ID: (not applicable for related donor)

___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ - Go to question 8

5. Non-NMDP cord blood unit ID: (include related and autologous CBUs)

___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

6. Is the CBU ID also the ISBT DIN: number?

 Yes – Go to question 8

 No – Go to question 7

7. Specify the ISBT DIN number: _____________________________________________

8. Registry or UCB Bank ID: ___ ___ ___ ___

9. Specify other Registry or UCB Bank:

10. Date of birth (donor / infant):

 Known – Go to question 11

 Unknown – Go to question 12

11. Date of birth (donor / infant): ___ ___ ___ ___ — ___ ___ — ___ ___ - Go to question 14

12. Age (donor / infant):

 Known – Go to question 13

 Unknown – Go to question 14

13. Age (donor / infant): ___ ___  Months (use only if less than 1 year old)

  Years

14. Sex (donor / infant):

 Male

 Female

15. Was the product derived from an NMDP adult donor, NMDP cord blood unit, or non-NMDP cord blood unit?

 Yes – Go to questions 43

 No – Go to question 16

Pre-Collection Therapy

16. Did the donor receive therapy, prior to any stem cell harvest, to enhance the product collection for this HCT?

 Yes – Go to questions 17

 No – Go to question 28

Specify therapy(s):

17. Growth and mobilizing factor(s)

 Yes – Go to questions 18

 No – Go to question 24

Specify growth factor(s):

18. G-CSF

 Yes

 No

19. Pegylated G-CSF

 Yes

 No

20. GM-CSF

 Yes

 No

21. Plerixafor (Mozobil)

 Yes

 No

22. Other growth or mobilizing factor

 Yes – Go to question 23

 No – Go to question 24

23. Specify other growth or mobilizing factor:

24. Systemic therapy (chemotherapy) (autologous only)

 Yes – Go to question 25

 No – Go to question 26

25. Anti-CD20 (rituximab, Rituxan) (autologous only)

 Yes

 No

26. Other therapy

 Yes – Go to question 27

 No – Go to question 28

27. Specify other therapy:

Product Collection

28. Date of first collection for this mobilization: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

29. Was more than one collection required for this HCT?

 Yes – Go to question 30

 No – Go to question 31

Complete a separate CIBMTR form 2006 – HCT Infustion for each subsequent collection that was not part of this mobilization.

30. Specify the number of subsequent days of collection in this episode: ___

31. Were anticoagulants added to the product during collection?

 Yes – Go to questions 32

 No – Go to question 37

Specify anticoagulant(s):

32. Acid citrate dextrose (ACD)

 Yes

 No

33. Citrate phosphate dextrose (CPD)

 Yes

 No

34. Heparin

 Yes

 No

35. Other anticoagulant

 Yes – Go to question 36

 No – Go to question 37

36. Specify other anticoagulant:

37. Were anticoagulants added to the product before freezing?

 Yes – Go to questions 38

 No – Go to question 43

Specify anticoagulant(s):

38. Acid citrate dextrose (ACD)

 Yes

 No

39. Citrate phosphate dextrose (CPD)

 Yes

 No

40. Heparin

 Yes

 No

41. Other anticoagulant

 Yes – Go to question 42

 No – Go to question 43

42. Specify:

Product Transport and Receipt

43. Was this product collected off-site and shipped to your facility?

 Yes – Go to question 44

 No – Go to question 57

44. Date of receipt of product at your facility: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

45. Time of receipt of product (24-hour clock): ___ ___ : ___ ___  standard time

^{Hour Minute}  daylight savings time

46. Specify the shipping environment of the product(s):

 Frozen gel pack (refrigerator temperature) – If product is cord blood, go to question 48; all other products go to question 57

 Frozen cord blood unit(s) – Go to question 48

 Room temperature per transplant center request – If product is cord blood, go to question 48; all other products go to question 57

 Other shipping environment – Go to question 47

47. Specify other shipping environment:
    – If product is cord blood, go to question 48; all other products go to question 57

48. Was there any indication that the environment within the shipper was outside the expected temperature range for this product at any time during shipment? (Cord blood units only)

 Yes

 No

49. Were the secondary containers (e.g., insulated shipping containers and unit cassette) intact when they arrived at your center? (Cord blood units only)

 Yes

 No

50. Was the cord blood unit stored at your center prior to thawing? (Cord blood units only)

 Yes – Go to questions 51

 No – Go to question 54

51. Specify the storage method used for the cord blood unit:

 Electric freezer

 Liquid nitrogen

 Vapor phase

52. Temperature during storage:

 < -150° C

 ≥ -150° C to < -135° C

 ≥ -135° C to < -80° C

 ≥ -80° C

53. Date storage started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

Report the total number of cells (not cells per kilogram) prior to cryopreservation: (Information provided for the unit by the cord blood bank).

54. Total nucleated cells: ___ ___ ___ ___ ● ___ ___ x 10 ___ ___ (Includes nucleated red and nucleated white cells) (Cord blood units only)

55. CD34+ cells (Cord blood units only)

Done – Go to question 56

Not done – Go to question 57

56. Total number of CD34+ cells: ___ ___ ___ ___ ● ___ ___ x 10 ___ ___

Product Processing / Manipulation

57. Was a fresh product received (e.g. not frozen)? (NMDP products only)

 Yes – Go to question 58

 No – Go to question 59

 Not applicable (cord blood unit) – Go to question 59

58. Was the entire fresh product cryopreserved at your facility prior to infusion? (NMDP products only)

 Yes

 No

59. Was the product thawed from a cryopreserved state prior to infusion?

 Yes – Go to question 60

 No – Go to question 71

60. Was the entire product thawed?

 Yes – Go to question 64

 No – Go to questions 61

61. Was only a compartment of the bag thawed? (Cord blood units only)

 Yes

 No

62. Were there multiple product bags?

 Yes – Go to question 63

 No – Go to question 64

63. Specify number of bags thawed: ___ ___

64. Date thawing process initiated: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

65. Time at initiation of thaw (24-hour clock): ___ ___ : ___ ___  standard time

^{Hour Minute}  daylight savings time

66. Time product ready for infusion or expansion (24-hour clock): ___ ___ : ___ ___  standard time

^{Hour Minute}  daylight savings time

67. Was the primary container (e.g., cord blood unit bag) intact upon thawing?

 Yes

 No

68. What method was used to thaw the product?

 Waterbath – Go to question 70

 Electric warmer – Go to question 70

 Other method – Go to question 69

69. Specify other method:

70. Did any adverse events, incidents, or product complaints occur while preparing or thawing the product?

 Yes

 No

71. Was the product manipulated prior to infusion?

 Yes – Go to questions 72

 No – If autologous product, go to question 109; if allogeneic product, go to question 158

72. Specify portion manipulated:

 Entire product

 Portion of product

Specify all methods used to manipulate the product:

73. Washed

 Yes

 No

74. Diluted

 Yes

 No

75. Buffy coat enriched (buffy coat preparation)

 Yes

 No

76. B cell reduced

Yes

No

77. CD8 reduced

Yes

No

78. Plasma reduced (removal)

Yes

No

79. RBC reduced

Yes

No

80. Cultured (ex-vivo expansion)

 Yes

 No

81. Genetic manipulation (gene transfer / transduction)

 Yes

 No

82. PUVA treated

 Yes

 No

83. CD34 enriched (CD34+ selection)

 Yes

 No

84. CD133 enriched

 Yes

 No

85. Monocyte enriched

 Yes

 No

86. Mononuclear cells enriched

 Yes

 No

87. T-cell depletion

 Yes – Go to questions 88

 No – Go to question 94

Specify method:

88. Antibody affinity column

 Yes – Report the antibodies used for T-cell depletion at question 96

 No

89. Antibody coated plates

 Yes – Report the antibodies used for T-cell depletion at question 96

 No

90. Antibody coated plates and soybean lectin

 Yes – Report the antibodies used for T-cell depletion at question 96

 No

91. Antibody + toxin

 Yes – Report the antibodies used for T-cell depletion at question 96

 No

92. Immunomagnetic beads

 Yes – Report the antibodies used for T-cell depletion at question 96

 No

93. CD34 affinity column plus sheep red blood cell rosetting

 Yes

 No

94. Other cell manipulation

 Yes – Go to question 93

 No – Go to question 96

95. Specify other cell manipulation:

96. Were antibodies used during product manipulation?

 Yes – Go to questions 97

 No – Go to question 109

Specify antibodies:

97. Anti CD2

 Yes

 No

98. Anti CD3

 Yes

 No

99. Anti CD4

 Yes

 No

100. Anti CD5

 Yes

 No

101. Anti CD6

 Yes

 No

102. Anti CD7

 Yes

 No

103. Anti CD8

 Yes

 No

104. Anti CD19

 Yes

 No

105. α/β antibody

 Yes

 No

106. Anti CD52 (Campath)

 Yes

 No

107. Other antibody

 Yes – Go to question 108

 No – Go to question 109

108. Specify other antibody:

Autologous Products Only

The following section refers to autologous products only, including autologous cord blood; if this is not an autologous HCT, continue with the Product Analysis section at question 158.

109. Were tumor cells detected in the recipient or autologous product prior to HCT?

 Yes – Go to question 110

 No – Go to question 136

Specify tumor cell detection method used and site(s) of tumor cells:

110. Routine histopathology

 Yes – Go to questions 111

 No – Go to question 114

Specify site(s):

111. Circulating blood cells

 Yes

 No

 Not done

112. Bone marrow (in the interval between last systemic therapy and collection)

 Yes

 No

 Not done

113. Collected cells (before purging)

 Yes

 No

 Not done

114. Polymerase chain reaction (PCR)

 Yes – Go to questions 115

 No – Go to question 118

Specify site(s):

115. Circulating blood cells

 Yes

 No

 Not done

116. Bone marrow (in the interval between last systemic therapy and collection)

 Yes

 No

 Not done

117. Collected cells (before purging)

 Yes

 No

 Not done

118. Other molecular technique

 Yes – Go to questions 119

 No – Go to question 123

119. Specify method:

Specify site(s):

120. Circulating blood cells

 Yes

 No

 Not done

121. Bone marrow (in the interval between last systemic therapy and collection)

 Yes

 No

 Not done

122. Collected cells (before purging)

 Yes

 No

 Not done

123. Immunohistochemistry

 Yes – Go to questions 124

 No – Go to question 127

Specify site(s):

124. Circulating blood cells

 Yes

 No

 Not done

125. Bone marrow (in the interval between last systemic therapy and collection)

 Yes

 No

 Not done

126. Collected cells (before purging)

 Yes

 No

 Not done

127. Cell culture technique

 Yes – Go to questions 128

 No – Go to question 131

Specify site(s):

128. Circulating blood cells

 Yes

 No

 Not done

129. Bone marrow (in the interval between last systemic therapy and collection)

 Yes

 No

 Not done

130. Collected cells (before purging)

 Yes

 No

 Not done

131. Other technique

 Yes – Go to questions 132

 No – Go to question 136

132. Specify:

Specify site(s):

133. Circulating blood cells

 Yes

 No

 Not done

134. Bone marrow (in the interval between last systemic therapy and collection)

 Yes

 No

 Not done

135. Collected cells (before purging)

 Yes

 No

 Not done

136. Was the product treated to remove malignant cells (purged)?

 Yes – Go to question 137

 No – Go to question 158

Specify method(s) used:

137. Monoclonal antibody

 Yes – Go to question 138

 No – Go to question 139

138. Specify monoclonal antibody:

139. 4-hydroperoxycyclophosphamide (4HC)

 Yes

 No

140. Mafosfamide

 Yes

 No

141. Other drug

 Yes – Go to question 142

 No – Go to question 143

142. Specify other drug:

143. Elutriation

 Yes

 No

144. Immunomagnetic column

 Yes

 No

145. Toxin

 Yes – Go to question 146

 No – Go to question 147

146. Specify toxin:

147. CD34 selection (other than preparation of mononuclear fraction)

 Yes – Go to question 148

 No – Go to question 149

148. Specify method:

149. Other method

 Yes – Go to question 150

 No – Go to question 151

150. Specify:

Specify if tumor cells were detected in the graft after purging by each method used:

151. Routine histopathology

 Yes

 No

 Not done

152. Polymerase chain reaction (PCR)

 Yes

 No

 Not done

153. Other molecular technique

 Yes

 No

 Not done

154. Immunohistochemistry

 Yes

 No

 Not done

155. Cell culture technique

 Yes

 No

 Not done

156. Other

 Yes – Go to question 157

 No – Go to question 158

 Not done – Go to question 158

157. Specify:

Product Analysis (All Products)

Product Analysis

158. Specify the timepoint in the product preparation phase that the product was analyzed:

 Product arrival

 Pre-cryopreservation

 Post-thaw

 At infusion (final quantity infused)

159. Date of product analysis: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

160. Total volume of product plus additives : ___ ___ ___ ___ ● ___  mL

 g

In this section, report the total number of cells (not cells per kilogram) not corrected for viability.

161. Total nucleated cells (TNC) (Includes nucleated red and nucleated white cells)

Done – Go to question 162

Not done – Go to question 163

162. Total nucleated cells: ___ ___ ___ ___ ● ___ ___ x 10 ___ ___

163. Nucleated white blood cells

Done – Go to question 164

Not done – Go to question 165

164. Total number of nucleated white blood cells: ___ ___ ___ ___ ● ___ ___ x 10 ___ ___

165. Mononuclear cells

Done – Go to question 166

Not done – Go to question 167

166. Total number of mononuclear cells: ___ ___ ___ ___ ● ___ ___ x 10 ___ ___

167. Nucleated red blood cells

Done – Go to question 168

Not done – Go to question 169

168. Total number of nucleated red blood cells: ___ ___ ___ ___ ● ___ ___ x 10 ___ ___

169. CD34+ cells

Done – Go to question 170

Not done – Go to question 171

170. Total number of CD34+ cells: ___ ___ ___ ___ ● ___ ___ x 10 ___ ___

171. CD3+ cells

Done – Go to question 172

Not done – Go to question 173

172. Total number of CD3+ cells: ___ ___ ___ ___ ● ___ ___ x 10 ___ ___

173. CD3+CD4+ cells

Done – Go to question 174

Not done – Go to question 175

174. Total number of CD3+CD4+ cells: ___ ___ ___ ___ ● ___ ___ x 10 ___ ___

175. CD3+CD8+ cells

Done – Go to question 176

Not done – Go to question 177

176. Total number of CD3+CD8+ cells: ___ ___ ___ ___ ● ___ ___ x 10 ___ ___

177. Viability of cells

Done – Go to question 178

Not done – Go to question 181

178. Viability of cells: ___ ___ ___ %

179. Method of testing cell viability:

 7-AAD – Go to question 181

 Propidium iodide – Go to question 181

 Trypan blue – Go to question 181

 Other method – Go to question 180

180. Specify other method:

181. Were the colony-forming units (CFU) assessed after thawing? (cord blood units only)

 Yes – Go to questions 182

 No – Go to question 187

182. Was there growth?

 Yes

 No

183. Total CFU-GM

 Done – Go to question 184

Not done – Go to question 185

184. Total CFU-GM: ___ ___ ___ ___ ● ___ x 10 ___ ___

185. Total BFU-E

 Done – Go to question 186

Not done – Go to question 187

186. Total BFU-E: ___ ___ ___ ___ ● ___ x 10 ___ ___

187. Were cultures performed before infusion to test the product(s) for bacterial or fungal infection? (complete for all cell products)

 Yes – Go to questions 188

 No – Go to question 196

188. Specify results:

 Positive

 Negative

 Unknown

Specify organism code(s):

189. ___ ___ ___

190. ___ ___ ___

191. ___ ___ ___

192. ___ ___ ___

193. ___ ___ ___

194. ___ ___ ___

195. Specify organism:

Copy questions 158 -195 to report multiple instances of Product Analysis

‡ The codes for “other organism, specify” (codes 198, 209, 219 and 259) should rarely be needed; check with your microbiology lab or HSCT physician before using them.

Codes for Commonly Reported Organisms

Bacterial Infections

121 Acinetobacter

122 Actinomyces

123 Bacillus

124 Bacteroides (gracillis, uniformis, vulgaris, other species)

125 Bordetella pertussis (whooping cough)

126 Borrelia (Lyme disease)

127 Branhamella or Moraxella catarrhalis (other species)

128 Campylobacter (all species)

129 Capnocytophaga

171 Chlamydia pneumoniae

172 Other chlamydia, specify

113 Chlamydia, NOS

130 Citrobacter (freundii, other species)

131 Clostridium (all species except difficile)

132 Clostridium difficile

173 Corynebacterium jeikeium

133 Corynebacterium (all nondiptheria species)

101 Coxiella

134 Enterobacter

177 Enterococcus, vancomycin resistant (VRE)

135 Enterococcus (all species)

136 Escherichia (also E. coli)

137 Flavimonas oryzihabitans

138 Flavobacterium

139 Fusobacterium

144 Haemophilus (all species, including influenzae)

145 Helicobacter pylori

146 Klebsiella

147 Lactobacillus (bulgaricus, acidophilus, other species)

102 Legionella

103 Leptospira

148 Leptotrichia buccalis

149 Leuconostoc (all species)

104 Listeria

150 Methylobacterium

151 Micrococcus, NOS

112 Mycobacterium avium–intracellulare (MAC, MAI)

174 Mycobacterium species (cheloneae, fortuitum, haemophilum, kansasii, mucogenicum

110 Mycobacterium tuberculosis (tuberculosis, Koch bacillus)

175 Other mycobacterium, specify

176 Mycobacterium, NOS

105 Mycoplasma

152 Neisseria (gonorrhoea, meningitidis, other species)

106 Nocardia

153 Pasteurella multocida

154 Propionibacterium (acnes, avidum, granulosum, other species)

155 Proteus

156 Pseudomonas (all species except cepacia & maltophilia)

157 Pseudomonas or Burkholderia cepacia

158 Pseudomonas or Stenotrophomonas or Xanthomonas maltophilia

159 Rhodococcus

107 Rickettsia

160 Salmonella (all species)

161 Serratia marcescens

162 Shigella

163 Staphylococcus, coagulase negative (not aureus)

164 Staphylococcus aureus

165 Staphylococcus, NOS

166 Stomatococcus mucilaginosis

167 Streptococcus (all species except Enterococcus)

178 Streptococcus pneumoniae

168 Treponema (syphilis)

169 Vibrio (all species)

197 Multiple bacteria at a single site, specify bacterial codes

198 Other bacteria, specify ‡

501 Suspected atypical bacterial infection

502 Suspected bacterial infection

Fungal Infections

200 Candida, NOS

201 Candida albicans

206 Candida guillermondi

202 Candida krusei

207 Candida lusitaniae

203 Candida parapsilosis

204 Candida tropicalis

205 Candida (Torulopsis) glabrata

209 Other Candida, specify ‡

210 Aspergillus, NOS

211 Aspergillus flavus

212 Aspergillus fumigatus

213 Aspergillus niger

219 Other Aspergillus, specify ‡

220 Cryptococcus species

230 Fusarium species

261 Histoplasmosis

240 Zygomycetes, NOS

241 Mucormycosis

242 Rhizopus

250 Yeast, NOS

259 Other fungus, specify ‡

260 Pneumocystis (PCP / PJP)

503 Suspected fungal infection

Product Infusion

196. Date of this product infusion: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

197. Was more than one product infused? (e.g., marrow and PBSC, PBSC and cord blood, two different cords, etc.)

 Yes – Go to question 198

 No – Go to question 199

198. Was the product infusion described on this insert intended to produce hematopoietic engraftment?

 Yes

 No

199. Date infusion started: ___ ___ ___ ___ - ___ ___ - ___ ___

YYYY MM DD

200. Time product infusion initiated (24-hour clock): ___ ___ : ___ ___  standard time

^{Hour Minute}  daylight savings time

201. Date infusion stopped: ___ ___ ___ ___ - ___ ___ - ___ ___

YYYY MM DD

202. Time product infusion completed (24-hour clock): ___ ___ : ___ ___  standard time

^{Hour Minute}  daylight savings time

203. Total volume of product plus additives intended for infusion: ___ ___ ___ ___ ● ___ mL

204. Was the entire volume of product infused?

 Yes – Go to question 207

 No – Go to question 205

205. Specify what happened to the reserved portion:

 Discarded – Go to question 207

 Cryopreserved for future use – Go to question 207

 Other fate – Go to question 206

206. Specify other fate:

207. Specify the route of product infusion:

 Intravenous – Go to question 209

 Intramedullary – Go to question 209

 Intraperitoneal – Go to question 209

 Other route of infusion – Go to question 208

208. Specify other route of infusion:

The following questions refer to all stem cell products except for autologous marrow or autologous PBSC products. If this HCT used an autologous marrow or autologous PBSC product, continue with the signature lines.

209. Were there any adverse events or incidents associated with the stem cell infusion?

 Yes – Go to question 210

 No – Go to question 250

Specify the following adverse event(s):

210. Brachycardia

 Yes – Go to question 211

 No – Go to question 212

211. In the Medical Director's judgment, was the adverse event a direct result of the infusion?

 Yes

 No

212. Chest tightness / pain

 Yes – Go to question 213

 No – Go to question 214

213. In the Medical Director's judgment, was the adverse event a direct result of the infusion?

 Yes

 No

214. Chills at time of infusion

 Yes – Go to question 215

 No – Go to question 216

215. In the Medical Director's judgment, was the adverse event a direct result of the infusion?

 Yes

 No

216. Fever ≤ 103° F within 24 hours of infusion

 Yes – Go to question 217

 No – Go to question 218

217. In the Medical Director's judgment, was the adverse event a direct result of the infusion?

 Yes

 No

218. Fever > 103° F within 24 hours of infusion

 Yes – Go to question 219

 No – Go to question 220

219. In the Medical Director's judgment, was the adverse event a direct result of the infusion?

 Yes

 No

220. Gross hemoglobinuria

 Yes – Go to question 221

 No – Go to question 222

221. In the Medical Director's judgment, was the adverse event a direct result of the infusion?

 Yes

 No

222. Headache

 Yes– Go to question 223

 No – Go to question 224

223. In the Medical Director's judgment, was the adverse event a direct result of the infusion?

 Yes

 No

224. Hives

 Yes – Go to question 225

 No – Go to question 226

225. In the Medical Director's judgment, was the adverse event a direct result of the infusion?

 Yes

 No

226. Hypertension

 Yes – Go to question 227

 No – Go to question 228

227. In the Medical Director's judgment, was the adverse event a direct result of the infusion?

 Yes

 No

228. Hypotension

 Yes – Go to question 229

 No – Go to question 230

229. In the Medical Director's judgment, was the adverse event a direct result of the infusion?

 Yes

 No

230. Hypoxia requiring oxygen (O₂) support

 Yes – Go to question 231

 No – Go to question 232

231. In the Medical Director's judgment, was the adverse event a direct result of the infusion?

 Yes

 No

232. Nausea

 Yes – Go to question 233

 No – Go to question 234

233. In the Medical Director's judgment, was the adverse event a direct result of the infusion?

 Yes

 No

234. Rigors, mild

 Yes – Go to question 235

 No – Go to question 236

235. In the Medical Director's judgment, was the adverse event a direct result of the infusion?

 Yes

 No

236. Rigors, severe

 Yes – Go to question 237

 No – Go to question 238

237. In the Medical Director's judgment, was the adverse event a direct result of the infusion?

 Yes

 No

238. Shortness of breath (SOB)

 Yes – Go to question 239

 No – Go to question 240

239. In the Medical Director's judgment, was the adverse event a direct result of the infusion?

 Yes

 No

240. Tachycardia

 Yes – Go to question 241

 No – Go to question 242

241. In the Medical Director's judgment, was the adverse event a direct result of the infusion?

 Yes

 No

242. Vomiting

 Yes – Go to question 243

 No – Go to question 244

243. In the Medical Director's judgment, was the adverse event a direct result of the infusion?

 Yes

 No

244. Other expected AE

 Yes – Go to questions 245

 No – Go to question 247

245. Specify other expected AE:

246. In the Medical Director's judgment, was the adverse event a direct result of the infusion?

 Yes

 No

247. Other unexpected AE

 Yes – Go to questions 248

 No – Go to question 250

248. Specify other unexpected AE:

249. In the Medical Director's judgment, was the adverse event a direct result of the infusion?

 Yes

 No

Donor / Infant Demographic Information

This Donor Demographic Information section (questions 250–270) is to be completed for all non-NMDP allogeneic donors. If the stem cell product was from an NMDP donor or an autologous donor, continue with the signature lines.

250. Was the donor ever pregnant?

 Yes – Go to question 251

 No – Go to question 253

 Unknown – Go to question 253

 Not applicable (male donor or cord blood unit) – Go to question 253

251. Number of pregnancies

 Known – Go to question 252

 Unknown – Go to question 253

252. Specify number of pregnancies: ___ ___

253. Specify blood type:

 A

 B

 AB

 O

254. Specify Rh factor:

 Positive

 Negative

255. Did this donor have a central line placed?

 Yes – Go to question 256

 No – Go to question 258

 Not applicable (cord blood unit or marrow product) – Go to question 258

256. Specify the site of the central line placement:

 Femoral – Go to question 258

 Subclavian – Go to question 258

 Internal jugular – Go to question 258

 Other site – Go to question 257

257. Specify other site:

258. Ethnicity (donor):

 Hispanic or Latino

 Not Hispanic nor Latino

 Unknown

259. Race: (donor)

 White

 Black or African American

 Asian American Indian or Alaska Native

 American Indian or Alaska Native

 Native Hawaiian or Other Pacific Islander

 Not reported

 Unknown

260. Race detail: (donor)

 Eastern European

 Mediterranean

 Middle Eastern

 North Coast of Africa

 North American

 Northern European

 Western European

 White Caribbean

 White South or Central American

 Other White

 African (both parents born in Africa)

 African American

 Black Caribbean

 Black South or Central American

 Alaskan Native or Aleut

 North American Indian

 American Indian, South or Central America

 Caribbean Indian

 South Asian

 Filipino (Pilipino)

 Japanese

 Korean

 Chinese

 Vietnamese

 Other Southeast Asian

 Guamanian

 Hawaiian

 Samoan

 Other Pacific Islander

Copy questions 259 – 260 to report more than one race.

261. What is the biological relationship of the donor to the recipient?

 Sibling – Go to question 264

 Half-sibling – Go to question 264

 Syngeneic (identical) twin – Go to question 264

 Fraternal twin – Go to question 264

 Recipient’s child – Go to question 264

 Other biological relative – Go to question 262

 Unrelated – Go to question 264

262. Specify the biological relationship of the donor to the recipient:

 Mother – Go to question 264

 Father – Go to question 264

 Maternal aunt – Go to question 264

 Maternal uncle – Go to question 264

 Maternal cousin – Go to question 264

 Paternal aunt – Go to question 264

 Paternal uncle – Go to question 264

 Paternal cousin – Go to question 264

 Other biological relative – Go to question 263

263. Specify:

264. Was the donor / product tested for potentially transplantable genetic diseases?

 Yes – Go to questions 265

 No – If this is a related donor, go to question 272; all other donor types go to signature line

 Unknown – If this is a related donor, go to question 272; all other donor types go to signature line

Specify disease(s) tested:

265. Sickle cell anemia

 Yes – Go to question 266

 No - Go to question 267

266. Specify results:

 Positive

 Carrier of the trait

 Negative

267. Thalassemia

 Yes - Go to question 268

 No - Go to question 269

268. Specify results:

 Positive

 Carrier of the trait

 Negative

269. Other disease

 Yes – Go to question 270

 No – If this is a related donor, go to question 272; all other donor types go to signature line

270. Specify other disease:

271. Specify results:

 Positive

 Carrier of the trait

 Negative

The following questions (272–285) apply only to allogeneic related donors. If the stem cell product was from an autologous donor, Non-NMDP unrelated donor, NMDP donor, or was a cord blood unit, then continue with the signature lines.

272. Was the donor hospitalized (inpatient) during or after the collection?

 Yes

 No

273. Did the donor experience any life-threatening complications during or after the collection?

 Yes – Go to question 274

 No – Go to question 275

274. Specify:

275. Did the donor receive blood transfusions as a result of the collection?

 Yes – Go to question 276

 No – Go to question 280

276. Was the blood transfusion product autologous?

 Yes – Go to question 277

 No – Go to question 278

277. Specify number of units: ___ ___

278. Was the blood transfusion product allogeneic (homologous)?

 Yes – Go to question 279

 No – Go to question 280

279. Specify number of units: ___ ___

280. Did the donor die as a result of the collection?

 Yes – Go to question 281

 No – Go to question 282

281. Specify cause of death:

282. Did the recipient submit a research sample to the NMDP/CIBMTR repository? (Related donors only)

 Yes – Go to question 283

 No – Go to question 284

283. Research sample recipient ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

284. Did the donor submit a research sample to the NMDP/CIBMTR repository? (Related donors only)

 Yes – Go to question 285

 No – Go to signature line

285. Research sample donor ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

First Name:

Person completing form

Last Name:

E-mail address:

Date: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

CIBMTR Form 2006 INF revision 3 (page 36 of 36) June 2009 FINAL 12/11/2012<

Copyright © 2009 National Marrow Donor Program and

The Medical College of Wisconsin, Inc. All rights reserved.

Internal use: Document number F00481 revision 2 Replaces: F00481 version 1.0 July 2007