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NCT04824794 · ADVERSE EVENTS

Adverse events

GEN3014 Trial in Relapsed or Refractory Hematologic Malignancies · Source last updated 2026-05-19

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
Up to approximately 4 years 3 months
Other-event reporting threshold
0%

Safety set included all enrolled participants who received at least 1 dose of trial drug (GEN3014 or daratumumab SC). In the RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg arm, the participant underwent intraparticipant dose escalation in Cycle 1. As pre-specified, safety data were collected and are reported combined for both 0.2 and 0.6 mg/kg dose levels in this arm.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg

Participants with RRMM received GEN3014 at a dose of 0.2/0.6 mg/kg by IV infusion in 28-day treatment cycles. Intraparticipant dose escalation was performed in this arm (i.e., dose was escalated from 0.2-0.6 mg/kg).

1 / 11 / 11 / 1
RRMM Dose Escalation: GEN3014 2 mg/kg

Participants with RRMM received GEN3014 at a dose of 2 mg/kg by IV infusion in 28-day treatment cycles.

1 / 11 / 11 / 1
RRMM Dose Escalation: GEN3014 4 mg/kg

Participants with RRMM received GEN3014 at a dose of 4 mg/kg by IV infusion in 28-day treatment cycles.

1 / 33 / 31 / 3
RRMM Dose Escalation: GEN3014 8 mg/kg

Participants with RRMM received GEN3014 at a dose of 8 mg/kg by IV infusion in 28-day treatment cycles.

2 / 33 / 31 / 3
RRMM Dose Escalation: GEN3014 16 mg/kg

Participants with RRMM received GEN3014 at a dose of 16 mg/kg by IV infusion in 28-day treatment cycles.

6 / 1111 / 114 / 11
RRMM Dose Escalation: GEN3014 24 mg/kg

Participants with RRMM received GEN3014 at a dose of 24 mg/kg by IV infusion in 28-day treatment cycles.

4 / 55 / 52 / 5
R/R AML Dose Escalation: GEN3014 Dose Level 1

Participants with R/R AML received GEN3014 at dose level 1 (low dose) in 28-day treatment cycles.

4 / 55 / 53 / 5
RRMM Expansion Part A: GEN3014

Participants with anti-CD38 mAb-naive RRMM received GEN3014 IV infusion at a dose of 16 mg/kg in 28-day cycles during Expansion Part A.

6 / 119 / 115 / 11
R/R DLBCL Expansion Part A: GEN3014

Participants with R/R DLBCL received GEN3014 IV infusion at a dose of 16 mg/kg in 28-day cycles during Expansion Part A.

1 / 22 / 22 / 2
RRMM Expansion Part B: Daratumumab

Participants with anti-CD38 mAb-naive RRMM received daratumumab at a dose of 1,800 mg by subcutaneous (SC) injection in 28-day treatment cycles.

11 / 4334 / 439 / 43
RRMM Expansion Part B: GEN3014

Participants with anti-CD38 mAb-naive RRMM received GEN3014 IV infusion at a dose of 16 mg/kg in 28-day treatment cycles.

19 / 4545 / 454 / 45

Group identifiers: EG000: RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg · EG001: RRMM Dose Escalation: GEN3014 2 mg/kg · EG002: RRMM Dose Escalation: GEN3014 4 mg/kg · EG003: RRMM Dose Escalation: GEN3014 8 mg/kg · EG004: RRMM Dose Escalation: GEN3014 16 mg/kg · EG005: RRMM Dose Escalation: GEN3014 24 mg/kg · EG006: R/R AML Dose Escalation: GEN3014 Dose Level 1 · EG007: RRMM Expansion Part A: GEN3014 · EG008: R/R DLBCL Expansion Part A: GEN3014 · EG009: RRMM Expansion Part B: Daratumumab · EG010: RRMM Expansion Part B: GEN3014

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
    Infections and infestations
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      11
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      43
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Enterocolitis infectious
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      11
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      11
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      43
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Dyspnoea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      11
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      11
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      43
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Hypervolaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      11
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      43
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Sinus bradycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      11
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      43
      num Events
      0
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Staphylococcal infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      11
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      43
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Fibrin D dimer increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      11
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      11
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      43
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Rhinovirus infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      11
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      43
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Death
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      11
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      43
      num Events
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Atypical pneumonia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      11
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      43
      num Events
      0
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Gastroenteritis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      11
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      43
      num Events
      0
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      11
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      43
      num Events
      0
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Diarrhoea

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
    Infections and infestations
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      11
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      2
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      43
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Gastrointestinal infection
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      11
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      43
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Myalgia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      5
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      11
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      43
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Abdominal distension
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      11
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      43
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Bronchitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      11
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      43
      num Events
      0
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Blood urea increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      11
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
      num Events
      0
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      43
      num Events
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Dehydration
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      11
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      2
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      43
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Abdominal pain lower
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      11
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      11
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      43
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Vitreous floaters
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      11
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      43
      num Events
      0
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Arthritis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      11
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      43
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Epistaxis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      11
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      43
      num Events
      0
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    General physical health deterioration
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      11
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      43
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Thirst
Complete source fields
description
Safety set included all enrolled participants who received at least 1 dose of trial drug (GEN3014 or daratumumab SC). In the RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg arm, the participant underwent intraparticipant dose escalation in Cycle 1. As pre-specified, safety data were collected and are reported combined for both 0.2 and 0.6 mg/kg dose levels in this arm.
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    1
    description
    Participants with RRMM received GEN3014 at a dose of 0.2/0.6 mg/kg by IV infusion in 28-day treatment cycles. Intraparticipant dose escalation was performed in this arm (i.e., dose was escalated from 0.2-0.6 mg/kg).
    id
    EG000
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    1
    serious Num At Risk
    1
    title
    RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg
  2. deaths Num Affected
    1
    deaths Num At Risk
    1
    description
    Participants with RRMM received GEN3014 at a dose of 2 mg/kg by IV infusion in 28-day treatment cycles.
    id
    EG001
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    1
    serious Num At Risk
    1
    title
    RRMM Dose Escalation: GEN3014 2 mg/kg
  3. deaths Num Affected
    1
    deaths Num At Risk
    3
    description
    Participants with RRMM received GEN3014 at a dose of 4 mg/kg by IV infusion in 28-day treatment cycles.
    id
    EG002
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    RRMM Dose Escalation: GEN3014 4 mg/kg
  4. deaths Num Affected
    1
    deaths Num At Risk
    3
    description
    Participants with RRMM received GEN3014 at a dose of 8 mg/kg by IV infusion in 28-day treatment cycles.
    id
    EG003
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    2
    serious Num At Risk
    3
    title
    RRMM Dose Escalation: GEN3014 8 mg/kg
  5. deaths Num Affected
    4
    deaths Num At Risk
    11
    description
    Participants with RRMM received GEN3014 at a dose of 16 mg/kg by IV infusion in 28-day treatment cycles.
    id
    EG004
    other Num Affected
    11
    other Num At Risk
    11
    serious Num Affected
    6
    serious Num At Risk
    11
    title
    RRMM Dose Escalation: GEN3014 16 mg/kg
  6. deaths Num Affected
    2
    deaths Num At Risk
    5
    description
    Participants with RRMM received GEN3014 at a dose of 24 mg/kg by IV infusion in 28-day treatment cycles.
    id
    EG005
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    4
    serious Num At Risk
    5
    title
    RRMM Dose Escalation: GEN3014 24 mg/kg
  7. deaths Num Affected
    3
    deaths Num At Risk
    5
    description
    Participants with R/R AML received GEN3014 at dose level 1 (low dose) in 28-day treatment cycles.
    id
    EG006
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    4
    serious Num At Risk
    5
    title
    R/R AML Dose Escalation: GEN3014 Dose Level 1
  8. deaths Num Affected
    5
    deaths Num At Risk
    11
    description
    Participants with anti-CD38 mAb-naive RRMM received GEN3014 IV infusion at a dose of 16 mg/kg in 28-day cycles during Expansion Part A.
    id
    EG007
    other Num Affected
    9
    other Num At Risk
    11
    serious Num Affected
    6
    serious Num At Risk
    11
    title
    RRMM Expansion Part A: GEN3014
  9. deaths Num Affected
    2
    deaths Num At Risk
    2
    description
    Participants with R/R DLBCL received GEN3014 IV infusion at a dose of 16 mg/kg in 28-day cycles during Expansion Part A.
    id
    EG008
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    1
    serious Num At Risk
    2
    title
    R/R DLBCL Expansion Part A: GEN3014
  10. deaths Num Affected
    9
    deaths Num At Risk
    43
    description
    Participants with anti-CD38 mAb-naive RRMM received daratumumab at a dose of 1,800 mg by subcutaneous (SC) injection in 28-day treatment cycles.
    id
    EG009
    other Num Affected
    34
    other Num At Risk
    43
    serious Num Affected
    11
    serious Num At Risk
    43
    title
    RRMM Expansion Part B: Daratumumab
  11. deaths Num Affected
    4
    deaths Num At Risk
    45
    description
    Participants with anti-CD38 mAb-naive RRMM received GEN3014 IV infusion at a dose of 16 mg/kg in 28-day treatment cycles.
    id
    EG010
    other Num Affected
    45
    other Num At Risk
    45
    serious Num Affected
    19
    serious Num At Risk
    45
    title
    RRMM Expansion Part B: GEN3014
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      11
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      2
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      43
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Gastrointestinal infection
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      11
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      43
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Myalgia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      5
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      11
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      43
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Abdominal distension
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      11
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      43
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Bronchitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      11
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      43
      num Events
      0
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Blood urea increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      11
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
      num Events
      0
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      43
      num Events
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Dehydration
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      11
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      2
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      43
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Abdominal pain lower
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      11
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      11
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      43
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Vitreous floaters
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      11
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      43
      num Events
      0
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Arthritis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      11
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      43
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Epistaxis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      11
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      43
      num Events
      0
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    General physical health deterioration
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      11
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      43
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Thirst
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      11
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      43
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Enterocolitis infectious
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      11
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      11
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      43
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Dyspnoea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      11
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      11
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      43
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Hypervolaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      11
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      43
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Sinus bradycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      11
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      43
      num Events
      0
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Staphylococcal infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      11
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      43
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Fibrin D dimer increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      11
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      11
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      43
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Rhinovirus infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      11
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      43
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Death
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      11
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      43
      num Events
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Atypical pneumonia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      11
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      43
      num Events
      0
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Gastroenteritis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      11
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      43
      num Events
      0
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      11
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      2
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      43
      num Events
      0
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Diarrhoea
time Frame
Up to approximately 4 years 3 months

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Preserved source evidence · Not medical advice