Skip to content
Triangle logo TriangleGet started
← Full study record

NCT04234113 · ADVERSE EVENTS

Adverse events

Study of Nanrilkefusp Alfa Alone and With Pembrolizumab in Adult Patients With Advanced/Metastatic Solid Tumors · Source last updated 2026-03-27

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
AEs: from the start to 90 days after the end of study treatment, up to approximately 5 years 5 months; related serious AEs: collected beyond 90 days after the end of study treatment, up to approximately 5 years 5 months; deaths: consent signature to study end, up to approximately 5 years 5 months
Other-event reporting threshold
5%

Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. AEs which were not treatment-emergent AEs or AEs that started in the cross-over part (at or after the first pembrolizumab administration) were listed only and as such are not presented in this overview.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 0.25 μg/kg

Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.

2 / 33 / 33 / 3
Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 0.75 μg/kg

Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.

2 / 33 / 32 / 3
Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 1.5 μg/kg

Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.

1 / 33 / 32 / 3
Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 3 μg/kg

Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.

3 / 44 / 42 / 4
Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 6 μg/kg

Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.

0 / 33 / 32 / 3
Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 9 μg/kg

Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.

2 / 44 / 42 / 4
Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 12 μg/kg

Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.

1 / 66 / 62 / 6
Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 15 μg/kg

Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.

2 / 44 / 43 / 4
Part A1 (Nanrilkefusp Alfa Divided Dosing, Monotherapy), Nanrilkefusp Alfa 9 μg/kg

Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle twice a day as 2 divided doses (50%:50%) with the second dose on each treatment day administered 8 hours (±15 min) after the first dose.

3 / 55 / 52 / 5
Part A1 (Nanrilkefusp Alfa Divided Dosing, Monotherapy), Nanrilkefusp Alfa 12 μg/kg

Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle twice a day as 2 divided doses (50%:50%) with the second dose on each treatment day administered 8 hours (±15 min) after the first dose.

1 / 33 / 31 / 3
Part B (Nanrilkefusp Alfa Combined With Pembrolizumab), Nanrilkefusp Alfa 1.5 μg/kg

Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose. Pembrolizumab 200 mg was administered intravenously on day 1 of the 21-day treatment cycle.

1 / 33 / 30 / 3
Part B (Nanrilkefusp Alfa Combined With Pembrolizumab), Nanrilkefusp Alfa 3 μg/kg

Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose. Pembrolizumab 200 mg was administered intravenously on day 1 of the 21-day treatment cycle.

2 / 33 / 30 / 3
Part B (Nanrilkefusp Alfa Combined With Pembrolizumab), Nanrilkefusp Alfa 6 μg/kg

Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose. Pembrolizumab 200 mg was administered intravenously on day 1 of the 21-day treatment cycle.

6 / 77 / 74 / 7
Part B (Nanrilkefusp Alfa Combined With Pembrolizumab), Nanrilkefusp Alfa 9 μg/kg

Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose. Pembrolizumab 200 mg was administered intravenously on day 1 of the 21-day treatment cycle.

2 / 33 / 30 / 3
Part B (Nanrilkefusp Alfa Combined With Pembrolizumab), Nanrilkefusp Alfa 12 μg/kg

Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose. Pembrolizumab 200 mg was administered intravenously on day 1 of the 21-day treatment cycle.

2 / 55 / 51 / 5
Part B1 (Nanrilkefusp Alfa Divided Dosing, Combined With Pembrolizumab), Nanrilkefusp Alfa 9 μg/kg

Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle twice a day as 2 divided doses (50%:50%) with the second dose on each treatment day administered 8 hours (±15 min) after the first dose. Pembrolizumab 200 mg was administered intravenously on day 1 of the 21-day treatment cycle.

2 / 44 / 40 / 4
Part D (Nanrilkefusp Alfa Monotherapy, Expansion at the RP2D), Nanrilkefusp Alfa 12 μg/kg

Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.

26 / 5252 / 5219 / 52

Group identifiers: EG000: Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 0.25 μg/kg · EG001: Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 0.75 μg/kg · EG002: Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 1.5 μg/kg · EG003: Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 3 μg/kg · EG004: Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 6 μg/kg · EG005: Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 9 μg/kg · EG006: Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 12 μg/kg · EG007: Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 15 μg/kg · EG008: Part A1 (Nanrilkefusp Alfa Divided Dosing, Monotherapy), Nanrilkefusp Alfa 9 μg/kg · EG009: Part A1 (Nanrilkefusp Alfa Divided Dosing, Monotherapy), Nanrilkefusp Alfa 12 μg/kg · EG010: Part B (Nanrilkefusp Alfa Combined With Pembrolizumab), Nanrilkefusp Alfa 1.5 μg/kg · EG011: Part B (Nanrilkefusp Alfa Combined With Pembrolizumab), Nanrilkefusp Alfa 3 μg/kg · EG012: Part B (Nanrilkefusp Alfa Combined With Pembrolizumab), Nanrilkefusp Alfa 6 μg/kg · EG013: Part B (Nanrilkefusp Alfa Combined With Pembrolizumab), Nanrilkefusp Alfa 9 μg/kg · EG014: Part B (Nanrilkefusp Alfa Combined With Pembrolizumab), Nanrilkefusp Alfa 12 μg/kg · EG015: Part B1 (Nanrilkefusp Alfa Divided Dosing, Combined With Pembrolizumab), Nanrilkefusp Alfa 9 μg/kg · EG016: Part D (Nanrilkefusp Alfa Monotherapy, Expansion at the RP2D), Nanrilkefusp Alfa 12 μg/kg

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
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      4
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      3
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Malignant neoplasm progression
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Tumour haemorrhage
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Tumour pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Hypotension
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Surgical and medical procedures
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      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
      4
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Tumour excision
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      4
      num Events
      1
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      5
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Pyrexia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Death
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Device related thrombosis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    General physical health deterioration
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Malaise
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      5
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Cytokine release syndrome

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
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      4
      num Events
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
      num Events
      1
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      6
      num Events
      2
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      4
      num Events
      1
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      5
      num Events
      2
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      3
      num Events
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      3
      num Events
      1
    term
    Tumour pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      4
      num Events
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      6
      num Events
      2
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      4
      num Events
      2
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      5
      num Events
      4
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      3
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      2
      num At Risk
      3
      num Events
      2
    term
    Hypotension
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      4
      num Events
      1
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      5
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Hypertension
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Haematoma
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      4
      num Events
      12
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      3
      num Events
      8
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      4
      num Events
      34
    7. group Id
      EG006
      num Affected
      6
      num At Risk
      6
      num Events
      52
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      4
      num Events
      11
    9. group Id
      EG008
      num Affected
      4
      num At Risk
      5
      num Events
      11
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      3
      num Events
      22
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      3
      num Events
      5
    12. group Id
      EG011
      num Affected
      3
      num At Risk
      3
      num Events
      26
    term
    Pyrexia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
      num Events
      4
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      3
      num Events
      6
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      4
      num Events
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
      num Events
      1
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      6
      num Events
      16
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      4
      num Events
      2
    9. group Id
      EG008
      num Affected
      3
      num At Risk
      5
      num Events
      4
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      3
      num Events
      3
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      3
      num Events
      3
    12. group Id
      EG011
      num Affected
      2
      num At Risk
      3
      num Events
      2
    term
    Injection site reaction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
      num Events
      1
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      3
      num Events
      6
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      4
      num Events
      19
    7. group Id
      EG006
      num Affected
      6
      num At Risk
      6
      num Events
      38
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      4
      num Events
      4
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      5
      num Events
      7
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      3
      num Events
      10
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      3
      num At Risk
      3
      num Events
      38
    term
    Chills
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      4
      num Events
      3
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      3
      num Events
      2
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      4
      num Events
      3
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      6
      num Events
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      5
      num Events
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      3
      num Events
      1
    term
    Asthenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
      num Events
      1
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      6
      num Events
      2
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      4
      num Events
      2
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      5
      num Events
      2
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      3
      num Events
      1
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      3
      num Events
      1
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Fatigue
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      5
      num Events
      1
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      3
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Oedema peripheral
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      4
      num Events
      12
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
      num Events
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Influenza like illness
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      5
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Catheter site warmth
Complete source fields
description
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. AEs which were not treatment-emergent AEs or AEs that started in the cross-over part (at or after the first pembrolizumab administration) were listed only and as such are not presented in this overview.
event Groups
  1. deaths Num Affected
    3
    deaths Num At Risk
    3
    description
    Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.
    id
    EG000
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    2
    serious Num At Risk
    3
    title
    Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 0.25 μg/kg
  2. deaths Num Affected
    2
    deaths Num At Risk
    3
    description
    Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.
    id
    EG001
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    2
    serious Num At Risk
    3
    title
    Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 0.75 μg/kg
  3. deaths Num Affected
    2
    deaths Num At Risk
    3
    description
    Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.
    id
    EG002
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 1.5 μg/kg
  4. deaths Num Affected
    2
    deaths Num At Risk
    4
    description
    Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.
    id
    EG003
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    3
    serious Num At Risk
    4
    title
    Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 3 μg/kg
  5. deaths Num Affected
    2
    deaths Num At Risk
    3
    description
    Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.
    id
    EG004
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    0
    serious Num At Risk
    3
    title
    Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 6 μg/kg
  6. deaths Num Affected
    2
    deaths Num At Risk
    4
    description
    Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.
    id
    EG005
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    2
    serious Num At Risk
    4
    title
    Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 9 μg/kg
  7. deaths Num Affected
    2
    deaths Num At Risk
    6
    description
    Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.
    id
    EG006
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    1
    serious Num At Risk
    6
    title
    Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 12 μg/kg
  8. deaths Num Affected
    3
    deaths Num At Risk
    4
    description
    Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.
    id
    EG007
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    2
    serious Num At Risk
    4
    title
    Part A (Nanrilkefusp Alfa Monotherapy), Nanrilkefusp Alfa 15 μg/kg
  9. deaths Num Affected
    2
    deaths Num At Risk
    5
    description
    Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle twice a day as 2 divided doses (50%:50%) with the second dose on each treatment day administered 8 hours (±15 min) after the first dose.
    id
    EG008
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    3
    serious Num At Risk
    5
    title
    Part A1 (Nanrilkefusp Alfa Divided Dosing, Monotherapy), Nanrilkefusp Alfa 9 μg/kg
  10. deaths Num Affected
    1
    deaths Num At Risk
    3
    description
    Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle twice a day as 2 divided doses (50%:50%) with the second dose on each treatment day administered 8 hours (±15 min) after the first dose.
    id
    EG009
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    Part A1 (Nanrilkefusp Alfa Divided Dosing, Monotherapy), Nanrilkefusp Alfa 12 μg/kg
  11. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose. Pembrolizumab 200 mg was administered intravenously on day 1 of the 21-day treatment cycle.
    id
    EG010
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    Part B (Nanrilkefusp Alfa Combined With Pembrolizumab), Nanrilkefusp Alfa 1.5 μg/kg
  12. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose. Pembrolizumab 200 mg was administered intravenously on day 1 of the 21-day treatment cycle.
    id
    EG011
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    2
    serious Num At Risk
    3
    title
    Part B (Nanrilkefusp Alfa Combined With Pembrolizumab), Nanrilkefusp Alfa 3 μg/kg
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      4
      num Events
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
      num Events
      1
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      6
      num Events
      2
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      4
      num Events
      1
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      5
      num Events
      2
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      3
      num Events
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      3
      num Events
      1
    term
    Tumour pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      4
      num Events
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      6
      num Events
      2
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      4
      num Events
      2
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      5
      num Events
      4
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      3
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      2
      num At Risk
      3
      num Events
      2
    term
    Hypotension
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      4
      num Events
      1
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      5
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Hypertension
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Haematoma
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      4
      num Events
      12
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      3
      num Events
      8
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      4
      num Events
      34
    7. group Id
      EG006
      num Affected
      6
      num At Risk
      6
      num Events
      52
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      4
      num Events
      11
    9. group Id
      EG008
      num Affected
      4
      num At Risk
      5
      num Events
      11
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      3
      num Events
      22
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      3
      num Events
      5
    12. group Id
      EG011
      num Affected
      3
      num At Risk
      3
      num Events
      26
    term
    Pyrexia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
      num Events
      4
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      3
      num Events
      6
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      4
      num Events
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
      num Events
      1
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      6
      num Events
      16
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      4
      num Events
      2
    9. group Id
      EG008
      num Affected
      3
      num At Risk
      5
      num Events
      4
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      3
      num Events
      3
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      3
      num Events
      3
    12. group Id
      EG011
      num Affected
      2
      num At Risk
      3
      num Events
      2
    term
    Injection site reaction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
      num Events
      1
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      3
      num Events
      6
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      4
      num Events
      19
    7. group Id
      EG006
      num Affected
      6
      num At Risk
      6
      num Events
      38
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      4
      num Events
      4
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      5
      num Events
      7
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      3
      num Events
      10
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      3
      num At Risk
      3
      num Events
      38
    term
    Chills
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      4
      num Events
      3
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      3
      num Events
      2
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      4
      num Events
      3
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      6
      num Events
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      5
      num Events
      2
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      3
      num Events
      1
    term
    Asthenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
      num Events
      1
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      6
      num Events
      2
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      4
      num Events
      2
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      5
      num Events
      2
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      3
      num Events
      1
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      3
      num Events
      1
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Fatigue
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      5
      num Events
      1
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      3
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Oedema peripheral
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      4
      num Events
      12
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
      num Events
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Influenza like illness
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      5
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Catheter site warmth
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      4
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      3
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Malignant neoplasm progression
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Tumour haemorrhage
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Tumour pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Hypotension
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Surgical and medical procedures
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      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
      4
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Tumour excision
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      4
      num Events
      1
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      5
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Pyrexia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Death
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Device related thrombosis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    General physical health deterioration
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Malaise
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      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
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      5
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Cytokine release syndrome
time Frame
AEs: from the start to 90 days after the end of study treatment, up to approximately 5 years 5 months; related serious AEs: collected beyond 90 days after the end of study treatment, up to approximately 5 years 5 months; deaths: consent signature to study end, up to approximately 5 years 5 months

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice