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NCT03180736 · ADVERSE EVENTS

Adverse events

Comparison of Pom and Dex in Subjects With RRMM Previously Treated With Len and a PI Dara/Pom/Dex vs Pom/Dex · Source last updated 2025-12-19

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
Over a median follow-up of 39.6 months (clinical cutoff date: 31 May 2022; approximately an additional 23 months since the primary analysis).
Other-event reporting threshold
5.0%

Safety results are summarized for 299 patients (Pd arm: 150; DPd arm: 149). Almost all patients in the DPd arm (142/149) received daratumumab SC, per Amendment 1. Of the remaining 7 patients, 4 were switched to daratumumab SC and 3 discontinued treatment before the study was amended to SC administration. The safety information for the DPd arm is presented for all patients who received daratumumab IV and/or SC (n=149) and for patients who received daratumumab SC only (n=142).

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Pomalidomide+Dexamethasone

Patients (n=150) received pomalidomide 4 mg orally on Days 1 through 21 of each 28-day treatment cycle and dexamethasone 40 mg (or 20 mg for patients ≥75 years of age) orally on Days 1, 8, 15, and 22 of each 28-day treatment cycle.

60 / 150144 / 15088 / 150
Daratumumab+Pomalidomide+Dexamethasone

Patients (n=149) received: daratumumab SC (fixed dose of 1800 mg) or IV (16 mg/kg) at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, and every 4 weeks (Q4W) thereafter; pomalidomide at a dose of 4 mg orally on Days 1 through 21 of each 28-day treatment cycle; and dexamethasone at a dose of 40 mg (or 20 mg for patients ≥75 years of age) orally on Days 1, 8, 15, and 22 of each 28-day treatment cycle.Only 7 patients received Dara IV and are included in the overall reporting category(DaraPomDex) and the DaraSC subcategory is presented separately to define the safety of the SC dosing regimen.

80 / 149144 / 14982 / 149
Daratumumab (SC)+Pomalidomide+Dexamethasone

Patients (n=142) received: daratumumab SC (fixed dose of 1800 mg) at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, and every 4 weeks (Q4W) thereafter; pomalidomide at a dose of 4 mg orally on Days 1 through 21 of each 28-day treatment cycle; and dexamethasone at a dose of 40 mg (or 20 mg for patients ≥75 years of age) orally on Days 1, 8, 15, and 22 of each 28-day treatment cycle.

77 / 142137 / 14277 / 142
Daratumumab (IV)+Pomalidomide+Dexamethasone

Patients (n=7) received: daratumumab IV (fixed dose of 1800 mg) at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, and every 4 weeks (Q4W) thereafter; pomalidomide at a dose of 4 mg orally on Days 1 through 21 of each 28-day treatment cycle; and dexamethasone at a dose of 40 mg (or 20 mg for patients ≥75 years of age) orally on Days 1, 8, 15, and 22 of each 28-day treatment cycle.

3 / 77 / 75 / 7

Group identifiers: EG000: Pomalidomide+Dexamethasone · EG001: Daratumumab+Pomalidomide+Dexamethasone · EG002: Daratumumab (SC)+Pomalidomide+Dexamethasone · EG003: Daratumumab (IV)+Pomalidomide+Dexamethasone

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
    notes
    Pd: 2 deaths DPd: 3 deaths DPd (SC): 3 deaths
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      149
    3. group Id
      EG002
      num Affected
      23
      num At Risk
      142
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pd: 1 death DPd: 1 death DPd (SC): 1 death
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      149
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      142
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Lower respiratory tract infection
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      149
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      142
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Upper respiratory tract infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      149
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      142
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Bronchitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      149
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      142
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Febrile neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      149
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      142
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pd: 0 deaths DPd: 1 death DPd (SC): 0 deaths
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      149
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      142
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
    term
    Dyspnoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      149
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      142
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Pyrexia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      149
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      142
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    General physical health deterioration
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      149
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      142
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Syncope
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      149
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      142
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Diarrhea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    All deaths are reported as footnotes. The table only refers to the most common SAEs reported with ≥2% higher frequency in the DPd group compared to the Pd group. Pd: 0 deaths DPd: 1 death DPd (SC): 1 death
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      149
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      142
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Campylobacter infection

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      80
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      107
      num At Risk
      149
    3. group Id
      EG002
      num Affected
      103
      num At Risk
      142
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      7
    term
    Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      67
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      57
      num At Risk
      149
    3. group Id
      EG002
      num Affected
      55
      num At Risk
      142
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      7
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      49
      num At Risk
      149
    3. group Id
      EG002
      num Affected
      48
      num At Risk
      142
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      39
      num At Risk
      149
    3. group Id
      EG002
      num Affected
      38
      num At Risk
      142
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      149
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      142
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      7
    term
    Lymphopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      149
    3. group Id
      EG002
      num Affected
      31
      num At Risk
      142
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      7
    term
    Upper respiratory tract infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      149
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      142
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Pneumonia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      149
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      142
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
    term
    Lower respiratory tract infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      149
    3. group Id
      EG002
      num Affected
      21
      num At Risk
      142
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Bronchitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      43
      num At Risk
      149
    3. group Id
      EG002
      num Affected
      39
      num At Risk
      142
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      7
    term
    Fatigue
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      149
    3. group Id
      EG002
      num Affected
      33
      num At Risk
      142
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Asthenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      149
    3. group Id
      EG002
      num Affected
      27
      num At Risk
      142
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
    term
    Pyrexia
Complete source fields
description
Safety results are summarized for 299 patients (Pd arm: 150; DPd arm: 149). Almost all patients in the DPd arm (142/149) received daratumumab SC, per Amendment 1. Of the remaining 7 patients, 4 were switched to daratumumab SC and 3 discontinued treatment before the study was amended to SC administration. The safety information for the DPd arm is presented for all patients who received daratumumab IV and/or SC (n=149) and for patients who received daratumumab SC only (n=142).
event Groups
  1. deaths Num Affected
    88
    deaths Num At Risk
    150
    description
    Patients (n=150) received pomalidomide 4 mg orally on Days 1 through 21 of each 28-day treatment cycle and dexamethasone 40 mg (or 20 mg for patients ≥75 years of age) orally on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
    id
    EG000
    other Num Affected
    144
    other Num At Risk
    150
    serious Num Affected
    60
    serious Num At Risk
    150
    title
    Pomalidomide+Dexamethasone
  2. deaths Num Affected
    82
    deaths Num At Risk
    149
    description
    Patients (n=149) received: daratumumab SC (fixed dose of 1800 mg) or IV (16 mg/kg) at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, and every 4 weeks (Q4W) thereafter; pomalidomide at a dose of 4 mg orally on Days 1 through 21 of each 28-day treatment cycle; and dexamethasone at a dose of 40 mg (or 20 mg for patients ≥75 years of age) orally on Days 1, 8, 15, and 22 of each 28-day treatment cycle.Only 7 patients received Dara IV and are included in the overall reporting category(DaraPomDex) and the DaraSC subcategory is presented separately to define the safety of the SC dosing regimen.
    id
    EG001
    other Num Affected
    144
    other Num At Risk
    149
    serious Num Affected
    80
    serious Num At Risk
    149
    title
    Daratumumab+Pomalidomide+Dexamethasone
  3. deaths Num Affected
    77
    deaths Num At Risk
    142
    description
    Patients (n=142) received: daratumumab SC (fixed dose of 1800 mg) at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, and every 4 weeks (Q4W) thereafter; pomalidomide at a dose of 4 mg orally on Days 1 through 21 of each 28-day treatment cycle; and dexamethasone at a dose of 40 mg (or 20 mg for patients ≥75 years of age) orally on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
    id
    EG002
    other Num Affected
    137
    other Num At Risk
    142
    serious Num Affected
    77
    serious Num At Risk
    142
    title
    Daratumumab (SC)+Pomalidomide+Dexamethasone
  4. deaths Num Affected
    5
    deaths Num At Risk
    7
    description
    Patients (n=7) received: daratumumab IV (fixed dose of 1800 mg) at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, and every 4 weeks (Q4W) thereafter; pomalidomide at a dose of 4 mg orally on Days 1 through 21 of each 28-day treatment cycle; and dexamethasone at a dose of 40 mg (or 20 mg for patients ≥75 years of age) orally on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
    id
    EG003
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    3
    serious Num At Risk
    7
    title
    Daratumumab (IV)+Pomalidomide+Dexamethasone
frequency Threshold
5.0
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      80
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      107
      num At Risk
      149
    3. group Id
      EG002
      num Affected
      103
      num At Risk
      142
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      7
    term
    Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      67
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      57
      num At Risk
      149
    3. group Id
      EG002
      num Affected
      55
      num At Risk
      142
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      7
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      49
      num At Risk
      149
    3. group Id
      EG002
      num Affected
      48
      num At Risk
      142
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      39
      num At Risk
      149
    3. group Id
      EG002
      num Affected
      38
      num At Risk
      142
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      149
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      142
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      7
    term
    Lymphopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      149
    3. group Id
      EG002
      num Affected
      31
      num At Risk
      142
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      7
    term
    Upper respiratory tract infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      149
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      142
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Pneumonia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      149
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      142
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
    term
    Lower respiratory tract infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      149
    3. group Id
      EG002
      num Affected
      21
      num At Risk
      142
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Bronchitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      43
      num At Risk
      149
    3. group Id
      EG002
      num Affected
      39
      num At Risk
      142
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      7
    term
    Fatigue
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      149
    3. group Id
      EG002
      num Affected
      33
      num At Risk
      142
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Asthenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      149
    3. group Id
      EG002
      num Affected
      27
      num At Risk
      142
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
    term
    Pyrexia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pd: 2 deaths DPd: 3 deaths DPd (SC): 3 deaths
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      149
    3. group Id
      EG002
      num Affected
      23
      num At Risk
      142
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pd: 1 death DPd: 1 death DPd (SC): 1 death
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      149
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      142
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Lower respiratory tract infection
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      149
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      142
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Upper respiratory tract infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      149
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      142
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Bronchitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      149
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      142
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Febrile neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      149
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      142
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pd: 0 deaths DPd: 1 death DPd (SC): 0 deaths
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      149
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      142
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
    term
    Dyspnoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      149
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      142
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Pyrexia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      149
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      142
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    General physical health deterioration
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      149
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      142
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Syncope
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      149
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      142
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Diarrhea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    All deaths are reported as footnotes. The table only refers to the most common SAEs reported with ≥2% higher frequency in the DPd group compared to the Pd group. Pd: 0 deaths DPd: 1 death DPd (SC): 1 death
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      150
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      149
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      142
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Campylobacter infection
time Frame
Over a median follow-up of 39.6 months (clinical cutoff date: 31 May 2022; approximately an additional 23 months since the primary analysis).

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Preserved source evidence · Not medical advice