Trial Outcomes & Findings for Effectiveness of MORAb-003 in Women With Ovarian Cancer Who Have Relapsed After Platinum-Based Chemotherapy (NCT NCT00318370)
NCT ID: NCT00318370
Last Updated: 2015-09-09
Results Overview
Defined using modified Gynecologic Cancer Intergroup (GCIG) criteria: Number of participants who achieved a 50% response = \>50% decrease from baseline CA-125 (higher of 2 pretreatment CA-125 assessments and the level must be at least 52.5 kU/L).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
58 participants
Primary outcome timeframe
Baseline to response (up to 30 weeks)
Results posted on
2015-09-09
Participant Flow
The first 6 participants enrolled in this study were dosed at farletuzumab, 37.5 mg/m2. The next 6 participants were dosed at farletuzumab, 62.5 mg/m2. The remaining participants received farletuzumab, 100 mg/m2.
Participant milestones
| Measure |
Far Only
Farletuzumab only (Far Only): farletuzumab, 100 milligrams (mg)/square meter (m2).
|
Chemo Plus Far
Platinum-based Chemotherapy plus farletuzumab (Chemo+Far): farletuzumab, 100 mg/m2 plus paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle.
|
Maintenance Far Only
Maintenance Far Only: farletuzumab, 100 milligrams (mg)/square meter (m2) for those subjects who completed Period 2, Chemo Plus Far.
|
|---|---|---|---|
|
Period 1
STARTED
|
28
|
0
|
0
|
|
Period 1
COMPLETED
|
21
|
0
|
0
|
|
Period 1
NOT COMPLETED
|
7
|
0
|
0
|
|
Period 2
STARTED
|
0
|
47
|
0
|
|
Period 2
COMPLETED
|
0
|
36
|
0
|
|
Period 2
NOT COMPLETED
|
0
|
11
|
0
|
|
Period 3
STARTED
|
0
|
0
|
36
|
|
Period 3
COMPLETED
|
0
|
0
|
3
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
33
|
Reasons for withdrawal
| Measure |
Far Only
Farletuzumab only (Far Only): farletuzumab, 100 milligrams (mg)/square meter (m2).
|
Chemo Plus Far
Platinum-based Chemotherapy plus farletuzumab (Chemo+Far): farletuzumab, 100 mg/m2 plus paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle.
|
Maintenance Far Only
Maintenance Far Only: farletuzumab, 100 milligrams (mg)/square meter (m2) for those subjects who completed Period 2, Chemo Plus Far.
|
|---|---|---|---|
|
Period 1
Lack of Efficacy
|
5
|
0
|
0
|
|
Period 1
Physician Decision
|
1
|
0
|
0
|
|
Period 1
Withdrawal by Subject
|
1
|
0
|
0
|
|
Period 2
Adverse Event
|
0
|
3
|
0
|
|
Period 2
Lack of Efficacy
|
0
|
5
|
0
|
|
Period 2
Physician Decision
|
0
|
1
|
0
|
|
Period 2
Withdrawal by Subject
|
0
|
1
|
0
|
|
Period 2
Other
|
0
|
1
|
0
|
|
Period 3
Adverse Event
|
0
|
0
|
1
|
|
Period 3
Lack of Efficacy
|
0
|
0
|
24
|
|
Period 3
Death
|
0
|
0
|
1
|
|
Period 3
Physician Decision
|
0
|
0
|
1
|
|
Period 3
Withdrawal by Subject
|
0
|
0
|
3
|
|
Period 3
Other
|
0
|
0
|
3
|
Baseline Characteristics
Effectiveness of MORAb-003 in Women With Ovarian Cancer Who Have Relapsed After Platinum-Based Chemotherapy
Baseline characteristics by cohort
| Measure |
Far Only and Chemo Plus Far and Maintenance Far Only
n=54 Participants
Farletuzumab only (Far Only): farletuzumab, 100 milligrams (mg)/square meter (m2).
Chemo+Far: paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle plus farletuzumab, 100 mg/m2.
Maintenance Far Only: farletuzumab, 100 milligrams (mg)/square meter (m2) for those subjects who completed the Period, Chemo Plus Far.
|
|---|---|
|
Age, Continuous
|
63.2 years
STANDARD_DEVIATION 11.66 • n=5 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
44 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to response (up to 30 weeks)Population: All participants enrolled to initial farletuzumab only.
Defined using modified Gynecologic Cancer Intergroup (GCIG) criteria: Number of participants who achieved a 50% response = \>50% decrease from baseline CA-125 (higher of 2 pretreatment CA-125 assessments and the level must be at least 52.5 kU/L).
Outcome measures
| Measure |
Far Only
n=21 Participants
Farletuzumab only (Far Only): farletuzumab, 100 milligrams (mg)/square meter (m2).
|
|---|---|
|
Serologic Response (Change in CA125 Level)
|
2 participants
Interval 0.9 to 23.5
|
PRIMARY outcome
Timeframe: Baseline to response (up to 27 weeks)Population: All participants enrolled to chemotherapy plus farletuzumab.
Defined using modified Gynecologic Cancer Intergroup (GCIG) criteria: Number of participants who had a 50% response = \>50% decrease from baseline CA-125 (higher of 2 pretreatment CA-125 assessments and the level must be at least 52.5 kU/L).
Outcome measures
| Measure |
Far Only
n=47 Participants
Farletuzumab only (Far Only): farletuzumab, 100 milligrams (mg)/square meter (m2).
|
|---|---|
|
Serologic Response (Change in Cancer Antigen [CA-125] Level)
|
41 participants
Interval 74.3 to 95.2
|
SECONDARY outcome
Timeframe: Baseline to response (up to 27 weeks)Population: All participants enrolled to intial chemotherapy plus farletuzumab.
Time to Serologic Response is defined as the time (weeks) from the date of first farletuzumab infusion to first documentation of 50% decrease from baseline CA-125 (higher of 2 pretreatment CA-125 assessments and at least twice the upper limit of normal) and then confirmed after 21 days.
Outcome measures
| Measure |
Far Only
n=47 Participants
Farletuzumab only (Far Only): farletuzumab, 100 milligrams (mg)/square meter (m2).
|
|---|---|
|
Time to Serologic Response (Change in CA-125 Level)
|
3.3 Weeks
Interval 3.1 to 6.1
|
SECONDARY outcome
Timeframe: Baseline to response (up to 44 months)Population: All participants enrolled to initial chemotherapy plus farletuzumab.
Calculated as the time from the first documentation of 50% or greater reduction in CA-125 to the first documentation of serologic progression or death due to any cause. Serologic progression was defined as the first date of the CA-125 level being \>2 X ULN on two occasions.
Outcome measures
| Measure |
Far Only
n=47 Participants
Farletuzumab only (Far Only): farletuzumab, 100 milligrams (mg)/square meter (m2).
|
|---|---|
|
Duration of Serologic Response (CA-125)
|
NA Months
Interval 9.9 to
NA = Not Estimable because the median number of participants did not progress or die.
|
SECONDARY outcome
Timeframe: Baseline to response (up to 44 months)The Overall Response Rate (ORR) will be determined by applying standard RECIST criteria to objective measures of disease, such as CT or MRI scans. Participants will be assigned to one of the categories of change in disease status, namely, "complete response" (CR), "partial response" (PR), "stable disease" (SD), or "progressive disease" (PD). ORR is defined as the percentage of participants with objective evidence of CR or PR.
Outcome measures
| Measure |
Far Only
n=47 Participants
Farletuzumab only (Far Only): farletuzumab, 100 milligrams (mg)/square meter (m2).
|
|---|---|
|
Overall Response Rate
Complete Response
|
6.8 percentage of participants
|
|
Overall Response Rate
Partial Response
|
63.6 percentage of participants
|
|
Overall Response Rate
Stable Disease
|
20.5 percentage of participants
|
|
Overall Response Rate
Progressive Disease
|
4.5 percentage of participants
|
|
Overall Response Rate
Not Evaluable
|
6.8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to response (up to 44 months)Population: All participants who received chemotherapy plus farletuzumab as well as those who continued on maintenance farletuzumab.
PFS is defined for participants treated in Chemo Plus Far as the time (in months) from date of first dose in Chemo Plus Far until date of the first observation of progression based on first date of the CA-125 \>2 X ULN on two occasions, or date of death, whatever the cause. If progression or death is not observed for a participant, the PFS time is censored at the later date of last tumor assessment or CA125 assessment without evidence of progression prior to the date of initiation of further anti-tumor treatment.
Outcome measures
| Measure |
Far Only
n=47 Participants
Farletuzumab only (Far Only): farletuzumab, 100 milligrams (mg)/square meter (m2).
|
|---|---|
|
Progression-free Survival (PFS)
|
10.2 Months
Interval 7.4 to 13.1
|
SECONDARY outcome
Timeframe: Baseline to response (up to 44 months)Population: All participants who received chemotherapy plus farletuzumab as well as those who continued on maintenance farletuzumab.
Percentage of participants whose second remission was longer than their first remission. The length of remission will be determined for participants who attain CR or PR (or SD and investigator's assessment of clinical benefit). Prolongation of remission will be defined as a length of remission occurring on this study that is ≥ 1 day longer than the length of remission to the original therapy. The length of remission on this study (second remission) will be defined as the amount of time from the date of first CR or PR to the end of this remission.
Outcome measures
| Measure |
Far Only
n=39 Participants
Farletuzumab only (Far Only): farletuzumab, 100 milligrams (mg)/square meter (m2).
|
|---|---|
|
Percentage of Participants Who Had a Prolongation of Remission
|
25.6 percentage of participants
Interval 13.0 to 42.1
|
Adverse Events
Far Only and Chemo Plus Far and Maintenance Far Only
Serious events: 20 serious events
Other events: 54 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Far Only and Chemo Plus Far and Maintenance Far Only
n=54 participants at risk
Farletuzumab only (Far Only): farletuzumab, 100 milligrams (mg)/square meter (m2).
Chemo+Far: paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle plus farletuzumab, 100 mg/m2.
Maintenance Far Only: farletuzumab, 100 milligrams (mg)/square meter (m2) for those subjects who completed the Period, Chemo Plus Far.
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
3.7%
2/54
|
|
Gastrointestinal disorders
Diarrhoea
|
3.7%
2/54
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
3.7%
2/54
|
|
Gastrointestinal disorders
Subileus
|
3.7%
2/54
|
|
Gastrointestinal disorders
Constipation
|
1.9%
1/54
|
|
Gastrointestinal disorders
Rectal haemorrohage
|
1.9%
1/54
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.9%
1/54
|
|
Gastrointestinal disorders
Vomiting
|
1.9%
1/54
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.7%
2/54
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.7%
2/54
|
|
Blood and lymphatic system disorders
Anaemia of chronic disease
|
1.9%
1/54
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.9%
1/54
|
|
Infections and infestations
Urosepsis
|
3.7%
2/54
|
|
Infections and infestations
Clostridium colitis
|
1.9%
1/54
|
|
Infections and infestations
Diverticulitis
|
1.9%
1/54
|
|
Infections and infestations
Pneumonia
|
1.9%
1/54
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.7%
2/54
|
|
Metabolism and nutrition disorders
Dehydration
|
1.9%
1/54
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
1.9%
1/54
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
1.9%
1/54
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive airways disease exacerbated
|
1.9%
1/54
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.9%
1/54
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
1.9%
1/54
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.9%
1/54
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
1.9%
1/54
|
|
Cardiac disorders
Acute coronary syndrome
|
1.9%
1/54
|
|
Cardiac disorders
Aortic valve stenosis
|
1.9%
1/54
|
|
Cardiac disorders
Coronary artery disease
|
1.9%
1/54
|
|
General disorders
Adverse drug reaction
|
1.9%
1/54
|
|
General disorders
Chest discomfort
|
1.9%
1/54
|
|
General disorders
Injection site reaction
|
1.9%
1/54
|
|
Nervous system disorders
Grand mal convulsion
|
1.9%
1/54
|
|
Nervous system disorders
Nervous system disorder
|
1.9%
1/54
|
|
Nervous system disorders
Syncope
|
1.9%
1/54
|
|
Vascular disorders
Aortic stenosis
|
1.9%
1/54
|
|
Vascular disorders
Deep vein thrombosis
|
1.9%
1/54
|
|
Vascular disorders
Femoral artery occlusion
|
1.9%
1/54
|
|
Vascular disorders
Peripheral occlusive disease
|
1.9%
1/54
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.9%
1/54
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.9%
1/54
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
1.9%
1/54
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.9%
1/54
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
1.9%
1/54
|
|
Immune system disorders
Cytokine release syndrome
|
1.9%
1/54
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
1.9%
1/54
|
|
Investigations
Psychiatric evaluation
|
1.9%
1/54
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
1.9%
1/54
|
|
Renal and urinary disorders
Hydronephrosis
|
1.9%
1/54
|
Other adverse events
| Measure |
Far Only and Chemo Plus Far and Maintenance Far Only
n=54 participants at risk
Farletuzumab only (Far Only): farletuzumab, 100 milligrams (mg)/square meter (m2).
Chemo+Far: paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle plus farletuzumab, 100 mg/m2.
Maintenance Far Only: farletuzumab, 100 milligrams (mg)/square meter (m2) for those subjects who completed the Period, Chemo Plus Far.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
64.8%
35/54
|
|
Gastrointestinal disorders
Constipation
|
61.1%
33/54
|
|
Gastrointestinal disorders
Diarrhoea
|
48.1%
26/54
|
|
Gastrointestinal disorders
Vomiting
|
46.3%
25/54
|
|
Gastrointestinal disorders
Abdominal Pain
|
44.4%
24/54
|
|
Gastrointestinal disorders
Abdominal distension
|
24.1%
13/54
|
|
Gastrointestinal disorders
Abdominal pain upper
|
14.8%
8/54
|
|
Gastrointestinal disorders
Dyspepsia
|
14.8%
8/54
|
|
Gastrointestinal disorders
Oral pain
|
13.0%
7/54
|
|
Gastrointestinal disorders
Ascites
|
9.3%
5/54
|
|
Gastrointestinal disorders
Flatulence
|
7.4%
4/54
|
|
Gastrointestinal disorders
Hiatus hernia
|
7.4%
4/54
|
|
Gastrointestinal disorders
Stomatitis
|
7.4%
4/54
|
|
Gastrointestinal disorders
Abdominal pain lower
|
5.6%
3/54
|
|
Gastrointestinal disorders
Abdominal tenderness
|
5.6%
3/54
|
|
General disorders
Fatigue
|
94.4%
51/54
|
|
General disorders
Pyrexia
|
40.7%
22/54
|
|
General disorders
Chills
|
25.9%
14/54
|
|
General disorders
Oedema peripheral
|
25.9%
14/54
|
|
General disorders
Asthenia
|
16.7%
9/54
|
|
General disorders
Adverse drug reaction
|
14.8%
8/54
|
|
General disorders
Pain
|
13.0%
7/54
|
|
General disorders
Chest discomfort
|
9.3%
5/54
|
|
General disorders
Influenza-like illness
|
7.4%
4/54
|
|
General disorders
Mucosal inflammation
|
7.4%
4/54
|
|
General disorders
Chest pain
|
5.6%
3/54
|
|
General disorders
Infusion site pain
|
5.6%
3/54
|
|
General disorders
Malaise
|
5.6%
3/54
|
|
Infections and infestations
Urinary tract infection
|
35.2%
19/54
|
|
Infections and infestations
Nasopharyngitis
|
24.1%
13/54
|
|
Infections and infestations
Upper respiratory tract infection
|
13.0%
7/54
|
|
Infections and infestations
Bronchitis
|
11.1%
6/54
|
|
Infections and infestations
Pneumonia
|
5.6%
3/54
|
|
Infections and infestations
Sinusitis
|
5.6%
3/54
|
|
Nervous system disorders
Headache
|
50.0%
27/54
|
|
Nervous system disorders
Dizziness
|
20.4%
11/54
|
|
Nervous system disorders
Neuropathy peripheral
|
14.8%
8/54
|
|
Nervous system disorders
Neuropathy
|
11.1%
6/54
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
9.3%
5/54
|
|
Nervous system disorders
Hypoaesthesia
|
7.4%
4/54
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
37.0%
20/54
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
27.8%
15/54
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
16.7%
9/54
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
11.1%
6/54
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
7.4%
4/54
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.4%
4/54
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
5.6%
3/54
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
5.6%
3/54
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.6%
3/54
|
|
Blood and lymphatic system disorders
Anaemia
|
42.6%
23/54
|
|
Blood and lymphatic system disorders
Neutropenia
|
42.6%
23/54
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
37.0%
20/54
|
|
Blood and lymphatic system disorders
Leukopenia
|
14.8%
8/54
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
7.4%
4/54
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
44.4%
24/54
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.4%
11/54
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
18.5%
10/54
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
13.0%
7/54
|
|
Skin and subcutaneous tissue disorders
Erythema
|
9.3%
5/54
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
9.3%
5/54
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
5.6%
3/54
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
5.6%
3/54
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
27.8%
15/54
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
24.1%
13/54
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
18.5%
10/54
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
13.0%
7/54
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
9.3%
5/54
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.3%
5/54
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.4%
4/54
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
7.4%
4/54
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.6%
3/54
|
|
Metabolism and nutrition disorders
Anorexia
|
13.0%
7/54
|
|
Metabolism and nutrition disorders
Decreased appetite
|
11.1%
6/54
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.4%
4/54
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
7.4%
4/54
|
|
Metabolism and nutrition disorders
Dehydration
|
5.6%
3/54
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.6%
3/54
|
|
Investigations
Weight decreased
|
11.1%
6/54
|
|
Investigations
White blood cell count decreased
|
7.4%
4/54
|
|
Investigations
Haemoglobin decreased
|
5.6%
3/54
|
|
Investigations
Red blood cell count decreased
|
5.6%
3/54
|
|
Psychiatric disorders
Anxiety
|
16.7%
9/54
|
|
Psychiatric disorders
Depression
|
14.8%
8/54
|
|
Psychiatric disorders
Insomnia
|
14.8%
8/54
|
|
Vascular disorders
Hypertension
|
11.1%
6/54
|
|
Vascular disorders
Flushing
|
7.4%
4/54
|
|
Vascular disorders
Hypotension
|
7.4%
4/54
|
|
Vascular disorders
Hot flush
|
5.6%
3/54
|
|
Renal and urinary disorders
Haematuria
|
14.8%
8/54
|
|
Renal and urinary disorders
Dysuria
|
9.3%
5/54
|
|
Renal and urinary disorders
Urinary incontinence
|
5.6%
3/54
|
|
Injury, poisoning and procedural complications
Contusion
|
9.3%
5/54
|
|
Cardiac disorders
Tachycardia
|
5.6%
3/54
|
|
Eye disorders
Lacrimation increased
|
7.4%
4/54
|
|
Eye disorders
Vision blurred
|
7.4%
4/54
|
|
Ear and labyrinth disorders
Ear pain
|
9.3%
5/54
|
|
Ear and labyrinth disorders
Vertigo
|
9.3%
5/54
|
|
Immune system disorders
Seasonal allergy
|
7.4%
4/54
|
|
Immune system disorders
Cytokine release syndrome
|
5.6%
3/54
|
|
Immune system disorders
Hypersensitivity
|
5.6%
3/54
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60