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NCT00499616 · ADVERSE EVENTS

Adverse events

Combination Chemotherapy and Surgery With or Without Isotretinoin in Treating Young Patients With Neuroblastoma · Source last updated 2021-07-06

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
Not reported
Other-event reporting threshold
0%

SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Group 2 (Chemotherapy, Surgery)

2 courses of initial chemotherapy (6 wks) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Partial response (PR) to chemo go to observation. No PR: 2-6 additional courses of chemo (beginning course 3 - cyclophosphamide, etoposide, filgrastim, carboplatin, doxorubicin hydrochloride). No PR after additional chemotherapy proceed to retrieval chemo: cyclophosphamide and topotecan hydrochloride on days 1-5. Treatment with retrieval chemotherapy repeats every 21 days for up to 6 courses. Some patients may also undergo surgery.

2 / 175135 / 175Not reported / Not reported
Group 3 (Chemotherapy, Surgery)

4 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, filgrastim. Patients with a PR after chemo proceed to observation. No PR receive 2-4 additional courses of chemotherapy (beginning with course 5) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. No PR after additional chemo proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.

5 / 140114 / 140Not reported / Not reported
Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy)

8 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Patients \< 12 months of age with stg 3, 4, or 4S (not including liver metastases) disease who achieve a very good PR (VGPR) to chemo proceed to observation. Patients 12-18 months of age with stg 3 or 4 who achieve VGPR proceed to isotretinoin therapy. No VGPR proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.

8 / 8976 / 89Not reported / Not reported
Non-intermediate Risk Enrolled on Intermediate Risk Trial

The no treatment group assignment patients may have received some treatment on ANBL0531 but they were not evaluable on this study due to being non-intermediate risk and hence did not receive a treatment assignment on ANBL0531. Surgery: With the exception of patients with INSS 4S disease, patients undergo surgery to remove as much of the primary tumor and involved lymph nodes as can safely be accomplished.

1 / 4223 / 42Not reported / Not reported

Group identifiers: EG000: Group 2 (Chemotherapy, Surgery) · EG001: Group 3 (Chemotherapy, Surgery) · EG002: Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy) · EG003: Non-intermediate Risk Enrolled on Intermediate Risk Trial

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      175
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      140
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      89
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    13200-Anemia
  2. organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      175
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      140
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      89
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    46300-Intra-abdominal hemorrhage
  3. organ System
    General disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      175
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      140
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      89
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    24600-Death NOS
  4. organ System
    General disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      175
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      140
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      89
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    55700-Multi-organ failure
  5. organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      175
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      140
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      89
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    40600-Hepatobiliary disorders - Other specify
  6. organ System
    Infections and infestations
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      175
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      140
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      89
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    44800-Infections and infestations - Other specify
  7. organ System
    Infections and infestations
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      175
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      140
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      89
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    73700-Sepsis
  8. organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      175
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      140
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      89
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    80700-Tracheal obstruction
  9. organ System
    Investigations
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      175
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      140
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      89
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    17400-Blood bilirubin increased
  10. organ System
    Investigations
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      175
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      140
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      89
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    58300-Neutrophil count decreased
  11. organ System
    Investigations
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      175
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      140
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      89
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    65800-Platelet count decreased
  12. organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      175
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      140
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      89
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    10700-Acidosis

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      60
      num At Risk
      175
      num Events
      94
    2. group Id
      EG001
      num Affected
      64
      num At Risk
      140
      num Events
      102
    3. group Id
      EG002
      num Affected
      45
      num At Risk
      89
      num Events
      105
    4. group Id
      EG003
      num Affected
      14
      num At Risk
      42
      num Events
      14
    term
    13200-Anemia
  2. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      175
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      140
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      89
      num Events
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    17200-Blood and lymphatic system disorders - Other specify
  3. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      175
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      140
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      89
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    25800-Disseminated intravascular coagulation
  4. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      175
      num Events
      28
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      140
      num Events
      27
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      89
      num Events
      20
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    33300-Febrile neutropenia
  5. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      175
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      140
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      89
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    20000-Cardiac arrest
  6. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      175
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      140
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      89
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    51700-Left ventricular systolic dysfunction
  7. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      175
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      140
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      89
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    87100-Ventricular tachycardia
  8. organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      175
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      140
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      89
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    55000-Middle ear inflammation
  9. organ System
    Endocrine disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      175
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      140
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      89
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    29200-Endocrine disorders - Other specify
  10. organ System
    Eye disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      175
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      140
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      89
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    31900-Eye disorders - Other specify
  11. organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      175
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      140
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      89
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      42
      num Events
      2
    term
    10100-Abdominal distension
  12. organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      175
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      140
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      89
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    10300-Abdominal pain
Complete source fields
description
SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
event Groups
  1. description
    2 courses of initial chemotherapy (6 wks) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Partial response (PR) to chemo go to observation. No PR: 2-6 additional courses of chemo (beginning course 3 - cyclophosphamide, etoposide, filgrastim, carboplatin, doxorubicin hydrochloride). No PR after additional chemotherapy proceed to retrieval chemo: cyclophosphamide and topotecan hydrochloride on days 1-5. Treatment with retrieval chemotherapy repeats every 21 days for up to 6 courses. Some patients may also undergo surgery.
    id
    EG000
    other Num Affected
    135
    other Num At Risk
    175
    serious Num Affected
    2
    serious Num At Risk
    175
    title
    Group 2 (Chemotherapy, Surgery)
  2. description
    4 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, filgrastim. Patients with a PR after chemo proceed to observation. No PR receive 2-4 additional courses of chemotherapy (beginning with course 5) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. No PR after additional chemo proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
    id
    EG001
    other Num Affected
    114
    other Num At Risk
    140
    serious Num Affected
    5
    serious Num At Risk
    140
    title
    Group 3 (Chemotherapy, Surgery)
  3. description
    8 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Patients \< 12 months of age with stg 3, 4, or 4S (not including liver metastases) disease who achieve a very good PR (VGPR) to chemo proceed to observation. Patients 12-18 months of age with stg 3 or 4 who achieve VGPR proceed to isotretinoin therapy. No VGPR proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
    id
    EG002
    other Num Affected
    76
    other Num At Risk
    89
    serious Num Affected
    8
    serious Num At Risk
    89
    title
    Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy)
  4. description
    The no treatment group assignment patients may have received some treatment on ANBL0531 but they were not evaluable on this study due to being non-intermediate risk and hence did not receive a treatment assignment on ANBL0531. Surgery: With the exception of patients with INSS 4S disease, patients undergo surgery to remove as much of the primary tumor and involved lymph nodes as can safely be accomplished.
    id
    EG003
    other Num Affected
    23
    other Num At Risk
    42
    serious Num Affected
    1
    serious Num At Risk
    42
    title
    Non-intermediate Risk Enrolled on Intermediate Risk Trial
frequency Threshold
0
other Events
  1. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      60
      num At Risk
      175
      num Events
      94
    2. group Id
      EG001
      num Affected
      64
      num At Risk
      140
      num Events
      102
    3. group Id
      EG002
      num Affected
      45
      num At Risk
      89
      num Events
      105
    4. group Id
      EG003
      num Affected
      14
      num At Risk
      42
      num Events
      14
    term
    13200-Anemia
  2. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      175
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      140
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      89
      num Events
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    17200-Blood and lymphatic system disorders - Other specify
  3. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      175
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      140
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      89
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    25800-Disseminated intravascular coagulation
  4. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      175
      num Events
      28
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      140
      num Events
      27
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      89
      num Events
      20
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    33300-Febrile neutropenia
  5. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      175
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      140
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      89
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    20000-Cardiac arrest
  6. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      175
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      140
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      89
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    51700-Left ventricular systolic dysfunction
  7. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      175
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      140
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      89
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    87100-Ventricular tachycardia
  8. organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      175
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      140
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      89
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    55000-Middle ear inflammation
  9. organ System
    Endocrine disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      175
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      140
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      89
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    29200-Endocrine disorders - Other specify
  10. organ System
    Eye disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      175
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      140
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      89
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    31900-Eye disorders - Other specify
  11. organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      175
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      140
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      89
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      42
      num Events
      2
    term
    10100-Abdominal distension
  12. organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      175
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      140
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      89
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    10300-Abdominal pain
serious Events
  1. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      175
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      140
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      89
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    13200-Anemia
  2. organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      175
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      140
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      89
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    46300-Intra-abdominal hemorrhage
  3. organ System
    General disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      175
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      140
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      89
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    24600-Death NOS
  4. organ System
    General disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      175
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      140
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      89
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    55700-Multi-organ failure
  5. organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      175
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      140
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      89
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    40600-Hepatobiliary disorders - Other specify
  6. organ System
    Infections and infestations
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      175
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      140
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      89
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    44800-Infections and infestations - Other specify
  7. organ System
    Infections and infestations
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      175
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      140
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      89
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    73700-Sepsis
  8. organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      175
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      140
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      89
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    80700-Tracheal obstruction
  9. organ System
    Investigations
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      175
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      140
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      89
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    17400-Blood bilirubin increased
  10. organ System
    Investigations
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      175
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      140
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      89
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    58300-Neutrophil count decreased
  11. organ System
    Investigations
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      175
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      140
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      89
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    65800-Platelet count decreased
  12. organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      175
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      140
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      89
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    10700-Acidosis

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Preserved source evidence · Not medical advice