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NCT02933320 · ADVERSE EVENTS

Adverse events

BI-1206 and an Anti-CD20 Antibody in Patients With CD32b Positive B-cell Lymphoma or Leukaemia · Source last updated 2021-07-08

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
Safety data were collected from the date of written informed consent and continued for 125 days after the final administration of BI 1206 or rituximab
Other-event reporting threshold
0%

Trial terminated before part B opened. No patients in arm B.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase

BI-1206 given by IV infusion to all patients once weekly for a period of four weeks, patients will then have a follow-up period of four weeks (8 week period classified as induction therapy). BI-1206 single agent dose escalation phase: BI-1206 single agent dose escalation phase to determine the MTD or MAD and RP2D for evaluation of BI-1206.

10 / 1313 / 131 / 13
Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase

Arm 2, an investigation of combination treatment of BI-1206 with rituximab, involving an initial assessment of the appropriate dose of BI-1206 that can be given in combination with rituximab (combination dose escalation cohorts). Combination of BI-1206 with rituximab escalation phase: An investigation of combination treatment of BI-1206 with rituximab.

1 / 11 / 10 / 1
Part B: Arm1: BI-1206 Single Agent Expansion Phase

Part B Arm 1, an expansion cohort of up to 25 patients treated with single agent BI-1206 at the RP2D as determined in Part A Arm 1. Expansion to include a minimum of 12 CLL patients and six MCL patients. BI-1206 single agent expansion phase: BI-1206 single agent expansion phase at the RP2D.

0 / 00 / 00 / 0
Part B: Arm 2: Combination of BI-1206 With Rituximab Expansion Phase

Part B Arm 2, an expansion cohort of up to 25 patients treated with a combination of BI-1206 and rituximab at the RP2D as determined in Part A Arm 2. Expansion to include a minimum of 12 CLL patients and six MCL patients. Combination of BI-1206 with rituximab expansion phase: BI-1206 in combination with rituximab at the RP2D.

0 / 00 / 00 / 0

Group identifiers: EG000: Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase · EG001: Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase · EG002: Part B: Arm1: BI-1206 Single Agent Expansion Phase · EG003: Part B: Arm 2: Combination of BI-1206 With Rituximab Expansion Phase

Serious adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Atrial fibrillation
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Diarrhoea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Non-cardiac chest pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Abdominal abscess
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Lower respiratory tract infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Metapneumovirus infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Neutropenic sepsis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      13
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Pneumonia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      13
      num Events
      11
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
      num Events
      1
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Infusion related reaction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Hyperkalaemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Hyperuricaemia

Other reported adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      13
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      13
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      13
      num Events
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
      num Events
      1
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Tachycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Blepharitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Cataract
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Normal tension glaucoma
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Periorbital oedema
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Vision blurred
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Abdominal distension
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Abdominal pain upper
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      13
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      13
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Diarrhoea
Complete source fields
description
Trial terminated before part B opened. No patients in arm B.
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    13
    description
    BI-1206 given by IV infusion to all patients once weekly for a period of four weeks, patients will then have a follow-up period of four weeks (8 week period classified as induction therapy). BI-1206 single agent dose escalation phase: BI-1206 single agent dose escalation phase to determine the MTD or MAD and RP2D for evaluation of BI-1206.
    id
    EG000
    other Num Affected
    13
    other Num At Risk
    13
    serious Num Affected
    10
    serious Num At Risk
    13
    title
    Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase
  2. deaths Num Affected
    0
    deaths Num At Risk
    1
    description
    Arm 2, an investigation of combination treatment of BI-1206 with rituximab, involving an initial assessment of the appropriate dose of BI-1206 that can be given in combination with rituximab (combination dose escalation cohorts). Combination of BI-1206 with rituximab escalation phase: An investigation of combination treatment of BI-1206 with rituximab.
    id
    EG001
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    1
    serious Num At Risk
    1
    title
    Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase
  3. deaths Num Affected
    0
    deaths Num At Risk
    0
    description
    Part B Arm 1, an expansion cohort of up to 25 patients treated with single agent BI-1206 at the RP2D as determined in Part A Arm 1. Expansion to include a minimum of 12 CLL patients and six MCL patients. BI-1206 single agent expansion phase: BI-1206 single agent expansion phase at the RP2D.
    id
    EG002
    other Num Affected
    0
    other Num At Risk
    0
    serious Num Affected
    0
    serious Num At Risk
    0
    title
    Part B: Arm1: BI-1206 Single Agent Expansion Phase
  4. deaths Num Affected
    0
    deaths Num At Risk
    0
    description
    Part B Arm 2, an expansion cohort of up to 25 patients treated with a combination of BI-1206 and rituximab at the RP2D as determined in Part A Arm 2. Expansion to include a minimum of 12 CLL patients and six MCL patients. Combination of BI-1206 with rituximab expansion phase: BI-1206 in combination with rituximab at the RP2D.
    id
    EG003
    other Num Affected
    0
    other Num At Risk
    0
    serious Num Affected
    0
    serious Num At Risk
    0
    title
    Part B: Arm 2: Combination of BI-1206 With Rituximab Expansion Phase
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      13
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      13
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      13
      num Events
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
      num Events
      1
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Tachycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Blepharitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Cataract
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Normal tension glaucoma
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Periorbital oedema
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Vision blurred
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Abdominal distension
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Abdominal pain upper
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      13
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      13
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Diarrhoea
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Atrial fibrillation
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Diarrhoea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Non-cardiac chest pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Abdominal abscess
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Lower respiratory tract infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Metapneumovirus infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Neutropenic sepsis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      13
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Pneumonia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      13
      num Events
      11
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
      num Events
      1
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Infusion related reaction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Hyperkalaemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Hyperuricaemia
time Frame
Safety data were collected from the date of written informed consent and continued for 125 days after the final administration of BI 1206 or rituximab

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Preserved source evidence · Not medical advice