Table 2.
Case details of patients in control and centhaquine groups
| Control (N = 22) | Centhaquine (N = 23) | ||
|---|---|---|---|
| Patient no. | Case details | Patient no. | Case details |
| 01-004 |
Male, age 67 years; case of RTA, bleeding over nose & multiple abrasion over face Event occurrence: 3 December 2017 Reporting at hospital (as per hospital records): 3 December 2017 at 2:39 p.m. Received first dose of study drug: 3 December 2017 at 5:50 p.m. Surgery/procedure during hospitalization (if any): Open reduction and internal fixation (ORIF)-plating fracture proximal tibia right + ORIF herbert screw fixation fracture talus + tension band wiring fracture medial malleolus right on 4 December 2017. Proximal humerus left ORIF performed on 7 December 2017 |
01-001 |
Male, age 53 years, case of RTA, wound at right thigh with abnormal mobility at right thigh and knee. Active bleed from wound. Thigh x-ray shows compound grade III fracture in right femur. Multiple abrasion over right side of chest and right wrist joint Event occurrence (as per hospital records): 28 May 2017 at 6:30 p.m. Reporting at hospital: 28 May 2017 at 9:45 p.m. Received first dose of study drug: 29 May 2017 at 12:52 a.m. Surgery/procedure during hospitalization (if any): ORIF of right femur performed on 29 May 2017 |
| 01-005 |
Male, age 26 years; case of RTA Event occurrence (as per hospital records): 22 December 2017 at 9:00 p.m. Reporting at hospital: 23 December 2017 at 12:05 a.m. Received first dose of study drug: 23 December 2017 at 8:45 a.m. Surgery/procedure during hospitalization (if any): Closed reduction and intramedullary nailing fracture shaft femur right performed on 23 December 2017. ORIF-plating fracture proximal humerus performed on 26 December 2017. ORIF tension band wiring fracture olecranon performed on 26 December 2017 |
01-002 |
Male, age 24 years, case of RTA. Lower limb x-ray showed fractured femur shaft Event occurrence (as per hospital records): 12 October 2017 at 9:00 p.m. Reporting at hospital: 13 October 2017 at 4:33 a.m. Received first dose of study drug: 13 October 2017 at 8:00 a.m. Surgery/procedure during hospitalization (if any): Closed reduction + intramedullary nailing |
| 01-007 |
Male, age 28 years; case of RTA Event occurrence (as per hospital records): 8 June 2018 at 7:00 p.m. Reporting at hospital: 9 June 2018 at 12:15 a.m. Received first dose of study drug: 9 June 2018 at 3:00 a.m. Surgery/procedure during hospitalization (if any): None |
01-006 |
Male, age 52 years; case of RTA, left lower limb pain and bleeding right frontal abrasion Event occurrence (as per hospital records): 14 January 2018 at 6:00 a.m. Reporting at hospital: 14 January 2018 at 8:47 a.m. Received first dose of study drug: 14 January 2018 at 1:25 p.m. Surgery/procedure during hospitalization (if any): Debridement + cemented intramedullary nail + vacuum-assisted closure performed on 14 January 2018. Exchange nail with tibia nail and debridement performed on 23 January 2018. Free anterolateral thigh flap cover and split thickness skin graft vascularized by anterior tibial artery and vein performed on 25 January 2018 |
| 02-001 |
Male, age 31 years; case of RTA with blunt trauma abdomen with splenic laceration grade III with moderate haemoperitoneum with hepatitis Event occurrence (as per hospital records): 29 May 2017 at 10:00 a.m. Reporting at hospital: 29 May 2017 at 11:45 a.m. Received first dose of study drug: 29 May 2017 at 3:50 p.m. Surgery/procedure during hospitalization (if any): None |
01-008 |
Male, age 28 years; case of RTA, compound fracture right tibia fibula with posterior tibial artery injury Event occurrence (as per hospital records): 24 July 2018 at 6:00 p.m. Reporting at hospital: 24 July 2018 at 7:00 p.m. Received first dose of study drug: 24 July 2018 at 9:20 p.m. Surgery/procedure during hospitalization (if any): Exploration and repair of posterior tibia artery performed on 24 July 2018 Debridement intramedullary nailing posterior tibia arterial repair, cemented implantation performed on 26 July 2018. Debridement with skin grafting over raw area medial side of right leg performed on 27 July 2018 |
| 02-004 |
Female, age 31 years; case of ruptured ectopic pregnancy with pain in lower abdomen. Intraoperative finding: haemoperitoneum 800 mL dark altered blood present Event occurrence (as per hospital records): 25 January 2018 at 2:45 p.m. Reporting at hospital: 25 January 2018 at 2:45 p.m. Received first dose of study drug: 25 January 2018 at 5:30 p.m. Surgery/procedure during hospitalization (if any): Haemoperitoneum 800 mL dark altered blood was present (intraoperative finding). Right tube salpingectomy and left side tubal ligation performed on 25 January 2018 |
02-002 |
Male, age 50 years; case of RTA, injuries over right upper and lower limb with active bleeding and swelling and presented with inability to walk to bear weight on bilateral lower limb. Open grade IIIA fracture femur with closed fracture distal femur with intraarticular extension. Pubic diastasis with fracture superior pubic rami with sacroiliac joint disruption with soft tissue injury over bilateral feet Event occurrence (as per hospital records): 30 June 2017 at 4:05 p.m. Reporting at hospital: 30 June 2017 at 4:05 p.m. Received first dose of study drug: 30 June 2017 at 7:00 p.m. Surgery/procedure during hospitalization (if any): Closed reduction and internal fixation of fracture femur with Sirus femur nail. Closed reduction and internal fixation of fracture distal femur. Stabilization of pubic diastasis with pelvic external fixator |
| 02-005 |
Male, age 56 years; case of RTA with multiple ortho injuries, open fracture bilateral lower limb and compression fracture of D3, D4 and D7 vertebra Event occurrence (as per hospital records): 21 February 2018 at 5:00 p.m. Reporting at hospital: 21 February 2018 at 7:40 p.m. Received first dose of study drug: 21 February 2018 at 9:40 p.m. Surgery/procedure during hospitalization (if any): Close reduction and stabilization of fracture femur with application of spanning external fixator across knee. Close reduction and stabilization of fracture bilateral distal both bone leg with across ankle external fixator bilateral performed on 28 February 2018 |
02-003 |
Male, age 46 years; case of RTA with injuries over right upper and lower limb with active bleeding and swelling. Open grade IIIA fracture humerus right side with comminution. Open-grade IIIA fracture both bone leg right side with comminution. Compound knee with lateral patellar retinaculum right. Soft tissue injury right thigh. Fracture medial epicondyle humerus. Blunt trauma chest and abdomen Event occurrence (as per hospital records): 23 August 2017 at 4:30 p.m. Reporting at hospital: 23 August 2017 at 7:33 p.m. Received first dose of study drug: 23 August 2017 at 9:45 p.m. Surgery/procedure during hospitalization (if any): Application of external fixation right humerus, application of external fixation right leg., debridement and irrigation of arm, thigh and leg wound, lateral patellar retinaculum repair on 25 August 2017. ORIF with 2.4MM cortical screw. Right humerus medial epicondyle screw fixation. Debridement and irrigation of thigh and leg on 31 August 2017. Debridement and irrigation of wound with readjustment of external fixation right arm on 5 September 2017 |
| 02-007 |
Female, age 21 years; case of RTA with recurrent loss of consciousness, Degloving injury of right axilla extending dorsally to scapula with exposed brachial plexus and vessels. Degloving injury extending up to right elbow joint laterally with exposed muscles. Multiple right-side rib fractures with haemothorax. Head Injury: Small epidural haemorrhage with subarachnoid haemorrhage Event occurrence (as per hospital records): 5 March 2018 at 9:00 a.m. Reporting at hospital: 5 March 2018 at 9:50 a.m. Received first dose of study drug: 5 March 2018 at 1:35 p.m. Surgery/procedure during hospitalization (if any): Skin grafting with rib fixation performed on 7 March 2018 |
02-006 |
Male, age 60 years; case of RTA with pelvic fracture, pre-vesicle haematoma, extra-peritoneal rupture of urinary bladder, B/L nasal bone fracture and fracture roof of left orbit Event occurrence (as per hospital records): 26 February 2018 at 7:00 p.m. Reporting at hospital: 26 February 2018 at 9:20 p.m. Received first dose of study drug: 26 February 2018 at 11:30 p.m. Surgery/procedure during hospitalization (if any): Shoulder repair left side was performed on 1 March 2018. Anterior bladder was repaired om 23 March 2018 |
| 02-009 |
Male, age 26 years; case of RTA with blunt trauma abdomen with ortho injury Abrasion on Left (5 × 1 cm) and right leg, laceration (4 × 2 cm) right thigh, abrasion dorsum of B/L hand, laceration (3 × 1 cm) below chin Open grade II fracture shaft femur. On MRI knee: Intercondylar fracture with avulsion of posterior cruciate ligament from its tibial attachment. Marrow edema of bilateral femoral condyles, lateral tibial condyles, patellae CT abdomen: Moderate haemoperitoneum. Small mesenteric haematoma Event occurrence (as per hospital records): 22 March 2018 at 10:00 a.m. Reporting at hospital: 22 March 2018 at 11:30 a.m. Received first dose of study drug: 22 March 2018 at 1:35 p.m. Surgery/procedure during hospitalization (if any): None |
02-008 |
Male, age 35 years; case of RTA, transient loss of consciousness, pain in chest and abdomen, pain in back with shock. Abrasion left side of chest, large abrasion (25 × 25 cm) on back, abrasion right ear, laceration wound right temporo-parietal injury. USG abdomen-moderate fluid seen in peritoneal cavity. CT abdomen-American Association for Surgery of Trauma (AAST) grade III pancreatic injury with peripancreatic haematoma and active blood, AAST grade II splenic injury, AAST grade V left renal injury, lung contusion Event occurrence (as per hospital records): 6 March 2018 at 5:00 p.m. Reporting at hospital: 6 March 2018 at 6:15 p.m. Received first dose of study drug: 6 March 2018 at 8:00 p.m. Surgery/procedure during hospitalization (if any): Laparotomy with splenectomy performed on 7 March 2018 |
| 02-012 |
Male, age 37 years; case of RTA, loss of consciousness with bleeding from right ear and nasal cavity. Left lower limb fracture tibia, fracture left shaft femur with comminuted fracture left patella and Fracture parasymphyseal mandible with B/L condyle. Abnormal bony mobility left thigh with bony crepitus with tenderness, right-side facial swelling and abnormally mobile mandible and malocclusion present Event occurrence (as per hospital records): 3 July 2018 at 10:30 a.m. Reporting at hospital: 3 July 2018 at 2:25 p.m. Received first dose of study drug: 3 July 2018 at 3:05 p.m. Surgery/procedure during hospitalization (if any): Tibia nail (21 × 20), ORIF of fracture shaft femur with IMLN (11 × 40 cm) and fixation of fracture lateral condyle, ORIF-plating of fracture mandible performed on 4 July 2018 |
02-010 |
Male, age 24 years; case of fall from height. Pelvic fracture, haemoperitoneum, liver laceration, rhabdomyolysis, multiple rib fracture right side with pneumothorax. CT abdomen: Liver injury ASST grade II, moderate haemoperitoneum, pelvic fracture, mild bilateral pleural effusion with multiple rib fracture and right pneumothorax Event occurrence (as per hospital records): 7 June 2018 Reporting at hospital: 8 June 2018 at 11:56 a.m. Received first dose of study drug: 8 June 2018 at 2:30 p.m. Surgery/procedure during hospitalization (if any): Right acetabular plating with olecranon fracture repaired on 16 June 2018. Left fracture acetabulum repaired on 19 June 2018 |
| 02-013 |
Male, age 67 years; case of RTA with blunt trauma abdomen and chest. CT scan reveals subdural haematoma with subarachnoid haematoma and intraventricular haemorrhage. Fracture of left parietal bone extending into squamous and mastoid part of left temporal bone with opacification of mastoid air cells. Multi-detector row computed tomography whole abdomen reveals mesenteric haematoma, mild ascites, and multiple fractures Event occurrence (as per hospital records): 25 July 2018 at 7:30 a.m. Reporting at hospital: 25 July 2018 at 11:15 a.m. Received first dose of study drug: 25 July 2018 at 2:15 p.m. Surgery/Procedure during hospitalization (if any): None |
02-011 |
Male, age 61 years; case of RTA with wound over posterior aspect of right knee, pain in right knee, right thigh and right leg with pain in pelvic region. Lacerated wound over right proximal leg anterior aspect (4 × 5 cm). Lacerated wound over popliteal area (35 × 15 cm). Open grade IIIB fracture distal femur and proximal tibia right side with compound knee. Pubic diastasis with right sacroiliac joint disruption Event occurrence (as per hospital records): 22 June 2018 at 5:30 a.m. Reporting at hospital: 22 June 2018 at 12:30 p.m. Received first dose of study drug: 22 June 2018 at 2:20 p.m. Surgery/procedure during hospitalization (if any): Open reduction and stabilization of fracture distal femur and proximal tibia with external fixator across right knee performed on 23 June 2018. Closed reduction and stabilization of pubic diastasis with pelvic external fixator. Removal of pelvic external fixator. ORIF of pubic diastasis with anterior pelvic plate, split skin grafting on wound over right popliteal region with graft harvested from contra-lateral thigh was performed on 3 July 2018 |
| 02-016 |
Male, age 28 years; case of RTA, followed by vomiting, chest and abdomen pain Mesenteric injury with right tibia fracture. CT scan reveals splenic injury grade II, mesenteric haematoma with active extravasation of contrast, significant haemoperitoneum USG chest reveals bilateral pleural effusion Event occurrence (as per hospital records): 17 August 2018 Reporting at hospital: 17 August 2018 at 11:55 a.m. Received first dose of study drug: 17 August 2018 at 4:40 p.m. Surgery/procedure during hospitalization (if any): Exploratory laparotomy for blunt trauma abdomen and resection and anastomosis of jejunal segment with ligation of mesenteric bleeders was performed on 17 August 2018 Closed reduction and internal fixation of fracture tibia with tibial nail performed on 23 August 2018 |
02-014 |
Female, age 43 years; case of RTA, loss of consciousness, head injury, ENT bleed with chest and abdomen pain. Brain CT scan reveals head injury with non-haemorrhagic contusions, infarct in right thalamus with right parietal and left frontal subarachnoid haemorrhage with pneumocephalus. Evidence of comminuted depressed fracture all the walls of bilateral frontal and maxillary sinus and bilateral ethmoid septa with evidence of haemosinus, fracture bilateral nasal bones, bony nasal septum, left lateral pterygoid plate, all the walls of left orbit, medial and posterolateral walls and floors of right orbit. MRI spine reveals large haematoma in subcutaneous tissue in dorsal cervical region, prevertebral collection opposite C1-4 level, fracture of 1st rib on right side with right eye exposure keratopathy with conjunctival chemosis Event occurrence (as per hospital records): 8 August 2018 Reporting at hospital: 8 August 2018 at 5:10 a.m. Received first dose of study drug: 8 August 2018 at 1:20 p.m. Surgery/procedure during hospitalization (if any): Bilateral maxilla and left zygoma plating with soft tissue repair on face and scalp on 11 August 2018 |
| 05-005 |
Female, age 24 years; post-operative case of exploratory laparotomy followed by hysterectomy. Perforating molar pregnancy. Haemorrhagic collection in peritoneal cavity, B/L theca-lutein cysts, perforation at right border of cervix. Severe acidosis, hypotension due to haemorrhagic shock. Patient was admitted on 27 May 2018 with bleeding per vaginal and abdominal pain. The ultrasonography shows corrosive mole (molar pregnancy). The general condition of the patient was very poor, and patient was suffering from severe respiratory distress Event occurrence (as per hospital records): 1 June 2018 at 5:56 p.m. Reporting at hospital: 1 June 2018 at 5:56 p.m. Received first dose of study drug: 1 June 2018 at 7:00 p.m. Surgery/procedure during hospitalization (if any): Exploratory laparotomy followed by hysterectomy performed on 1 June 2018 |
02-015 |
Male, age 59 years; machine cut injury on right limbs and fell to ground and suffered laceration followed by bleeding from cut. Traumatic amputation right lower limb, sepsis, pneumonitis, and acute kidney injury (recovering phase) Event occurrence (as per hospital records): 17 August 2018 at 8:00 a.m. Reporting at hospital: 17 August 2018 at 10:25 a.m. Received first dose of study drug: 17 August 2018 at 12:15 p.m. Surgery/procedure during hospitalization (if any): Patient underwent haemodialysis |
| 05-007 |
Male, age 24 years; post-operative case of re-exploration of abdomen after open adrenalectomy. On 26 July 2018 resection of right-side supra-renal mass adrenalectomy done. On same day re-surgery was done to stop bleeding Event occurrence (as per hospital records): 26 July 2018 at 11:00 p.m. Reporting at hospital: 26 July 2018 at 11:00 p.m. Received first dose of study drug: 27 July 2018 at 2:00 a.m. Surgery/procedure during hospitalization (if any): On 26/07/2018 at 10:30 a.m. Resection of right-side supra-renal mass (Pheochromocytoma) adrenalectomy performed on 26 July 2018. Re-exploration of abdomen after open adrenalectomy on 26 July 2018. Re-surgery done to stop bleeding on 26 July 2018 |
05-003 |
Female, age 26 years; post-operative case of haemobilia, right hepatic artery pseudoaneurysm, status open cholecystectomy. Blood loss in the OT room. Cholestatic liver, no free fluid inside the abdomen. A 3 × 4-cm pseudoaneurysm arising from RHA palpated in lateral aspect of HDL. Pseudoaneurysm erodes the CBD near hilum. Pseudoaneurysm wall opened and around 100 cc clot removed Event occurrence (as per hospital records): 17 March 2018 at 8:55 p.m. Reporting at hospital: 17 March 2018 at 8:55 p.m. Received first dose of study drug: 18 March 2018 at 12:00 a.m. Surgery/procedure during hospitalization (if any): Excision of hepatic artery aneurysm and T-tube placement on 17 March 2018 |
| 08-003 |
Male, age 45 years; case of RTA followed by loss of consciousness, two episodes of vomiting, nasal bleed and wound over forehead. Right knee septic arthritis with open head injury with pneumocephalus with wound over frontal region right side secondary to accident with nasal bone fracture, supra- and infra-orbital rim fracture Event occurrence (as per hospital records): 18 July 2018 at 8:00 p.m. Reporting at hospital: 19 July 2018 at 12:00 a.m. Received first dose of study drug: 19 July 2018 at 12:30 a.m. Surgery/procedure during hospitalization (if any): Exploration and debridement of wound was performed on 19/07/2018 |
05-004 |
Male, age 43 years; post-traumatic post-infective fracture clavicle with suspected pseudoaneurysm at right shoulder. Excision of right clavicle bone exploration of right subclavian area done. Right subclavian artery seen ruptured with pseudoaneurysm and rupture of subclavian vein cuts repaired. Blood loss approximate 3 l Event occurrence (as per hospital records): 7 April 2018 at 5:36 p.m. Reporting at hospital: 7 April 2018 at 5:36 p.m. Received first dose of study drug: 7 April 2018 at 8:10 p.m. Surgery/procedure during hospitalization (if any): Right clavicular fracture and right clavicular fixation on 7 April 2018. Right subclavian artery pseudoaneurysm-vessel repaired |
| 08-005 |
Male, age 20 years; case of RTA, pubic (Pelnic) diastasis with sacrum fracture. MRI and CT scan revealed fracture of right transverse process of L5 vertebral body, comminuted fracture of S-3 vertebral body and posterior element posterior subluxation of proximal fracture fragments causing compression over corresponding traversing sacral nerve roots, comminuted fracture of transverse process of all sacral vertebrae involving neural foramina retro-peritoneal haematoma Event occurrence (as per hospital records): 16 September 2018 at 2:30 p.m. Reporting at hospital: 16 September 2018 at 09:35 p.m. Received first dose of study drug: 17 September 2018 at 11:30 a.m. Surgery/procedure during hospitalization (if any): ORIF with CC screw for scram fracture. ORIF with plating for pubic diastasis performed on 23 September 2018 |
05-006 |
Female, age 31 years; post-operative case of laparotomy followed by hysterectomy, placental abruption, and uterine rupture. Around 2 l blood found in peritoneal cavity. Tear found in anterior and posterior wall of uterus. Patient 19 weeks of gestation with lower abdominal pain USG suggesting amniotic membrane separation, retro-amniotic and retro-peritoneal collection, tear in right lateral uterine wall through which collection extended to peri-uterine region. Interloop fluid is also noted Event occurrence (as per hospital records): 29 June 2018 at 4:06 p.m. Reporting at hospital: 29 June 2018 at 3:30 a.m. Received first dose of study drug: 29 June 2018 at 6:30 p.m. Surgery/procedure during hospitalization (if any): Laparotomy followed by hysterectomy done due to placental abruption and uterine rupture with B/L internal Iliac artery ligation on 29 June 2018 |
| 10-001 |
Male, age 32 years; RTA with fracture left I/T neck of femur, fracture left tibia condyle with fibular head fracture with right-side pneumothorax. Undisplaced fracture in the anterior portion of right 7th rib. Liver shows subcapsular haematoma correspond to grade III–IV liver injury Event occurrence (as per hospital records): 29 May 2018 at 11:30 a.m. Reporting at hospital: 30 May 2018 at 9:45 a.m. Received first dose of study drug: 30 May 2018 at 1:15 p.m. Surgery/procedure during hospitalization (if any): ORIF with PFN and ORIF with tibia condyle plating performed for left I/T fracture with tibia condyle fracture on 1 June 2018 |
07-001 |
Male, age 52 years; patient complaint of altered sensorium, haematuria, stool melena, fever, vomiting, and breathlessness. History of fever, on and off with vomiting from 2 months. Diagnosis: multiple liver abscess, septicaemia, hyponatraemia, and generalized tonic clonic convulsion Event occurrence (as per hospital records): 13 January 2018 at 2:50 p.m. Reporting at hospital: 13 January 2018 at 2:45 p.m. Received first dose of study drug: 13 January 2018 at 6:22 p.m. Surgery/procedure during hospitalization (if any): None |
| 10-004 |
Male, age 51 years; patient underwent endoscopic retrograde cholangiopancreatography (ERCP) stenting for obstructive jaundice on 26 May 2018. Post-ERCP patient was in shock with distension of abdomen. CT abdomen showed duodenal perforation Event occurrence (as per hospital records): 6 June 2018 at 6:45 p.m. Reporting at hospital: 28 May 2018 at 6:45 p.m. Received first dose of study drug: 6 June 2018 at 11:10 p.m. Surgery/procedure during hospitalization (if any): Exploratory laparotomy, duodenum repair, cholecystectomy + CBD exploration, T tube insertion done, stone removed with right DJ stenting, feeding jejunostomy done on 6 June 2018 |
08-001 |
Male, age 27 years; case of RTA, head and neck injury, pain in neck, loss of sensation, seizures, vomiting. MRI spine-wedge compression fracture of the C5 vertebral body with retropulsion of the fracture fragment causing significant compression on the subarachnoid space and spinal cord resulting. CT brain-epidural haematoma noted in occipital region on left side, 6 mm on bone window, fracture of the parietal bone along the sagittal suture, subgaleal haematoma, noted in the parieto-temporal and occipital regions Event occurrence (as per hospital records): 29 March 2018 at 2:00 p.m. Reporting at hospital: 29 March 2018 at 4:15 p.m. Received first dose of study drug: 29 March 2018 at 9:33 p.m. Surgery/procedure during hospitalization (if any): C5 corpectomy with bone grafting with C4–C6 plating performed on 11 April 2018 |
| 10-005 |
Female, age 41 years; known case of obstructive uropathy intravenous pyelogram with moderate hydronephrosis, calculus in renal pelvis. Operated on 9 June 2018 for right percutaneous nephrolithotomy and left stenting done. This was an intra-operative case of hypovolemic shock Event occurrence (as per hospital records): 9 June 2018 at 8:00 p.m. Reporting at hospital: 9 June 2018 at 8:00 p.m. Received first dose of study drug: 9 June 2018 at 11:45 p.m. Surgery/procedure during hospitalization (if any): percutaneous nephrolithotomy and left DJ stenting performed on 9 June 2018 |
08-002 |
Male, age 30 years; case of RTA, sustained injury to right lower limb, knee, and thigh. Right-side type III B open distal 1/3rd comminuted tibia fibula fracture with bone loss and soft tissue loss. Open wound of (20 × 10 cm) over right lower leg and ankle. Right lower limb: Open comminuted fracture of right tibia and fibula bone exposed with bleeding. Soft tissue defect over anterior aspect of ankle. Anterior tendon and bone-exposed, abrasion wound over knee and thigh Event occurrence (as per hospital records): 31 March 2018 at 11:30 p.m. Reporting at hospital: 1 April 2018 at 6:10 a.m. Received first dose of study drug: 1 April 2018 at 12:03 p.m. Surgery/procedure during hospitalization (if any): External fixation for right tibia + TENS nail for fibula bone under spinal anaesthesia on 1 April 2018. Debridement of wound bone. IMIL nailing for right tibia fracture bone and debridement + split thickness skin grafts done on 10 April 2018 |
| 10-007 |
Female, age 28 years; patient admitted with the complaint of pain in lower abdomen, minimal PV bleeding, vomiting (10–12 times), fainting episode once. Retention of urine (catheterized outside) initially treated and referred to site for further management. Diagnosis: Left-side ruptured ectopic pregnancy Event occurrence (as per hospital records): 20 July 2018 at 5:32 p.m. Reporting at hospital: 20 July 2018 at 5:32 p.m. Received first dose of study drug: 20 July 2018 at 8:00 p.m. Surgery/procedure during hospitalization (if any): Laparoscopic salpingectomy performed on 20 July 2018 for ectopic pregnancy |
10-002 |
Male, age 24 years; patient admitted with complaint of active P/R bleeding, abdominal pain. Caecal telangiectasia with bleeding from caecum. USG abdomen and pelvis reveals mild ascites (bilateral iliac fossae and hepato-renal pouch) Event occurrence (as per hospital records): 30 May 2018 at 5:00 PM Reporting at hospital: 30 May 2018 at 5:00 p.m. Received first dose of study drug: 30 May 2018 at 9:00 p.m. Surgery/procedure during hospitalization (if any): Telangiectasia at IC junction with limited hemicolectomy performed on 30 May 2018 |
| 11-001 |
Female, age 19 years; case of haematemesis, black-coloured stool for 3 days (3–4 episodes per day). History of intermittent haematemesis and melaena for 6–7 years. Pallor + + UGG: Mild splenomegaly. CT abdomen: Ostial narrowing of celiac artery hepato-splenomegaly Event occurrence (as per hospital records): 17 June 2018 at 10:02 p.m. Reporting at hospital: 17 June 2018 at 10:02 p.m. Received first dose of study drug: 18 June 2018 at 11:53 a.m. Surgery/procedure during hospitalization (if any): None |
10-003 |
Female, age 30 years; admitted with complaint of bilateral ovarian masses. CT abdomen and pelvis reveals bilateral ovarian masses with multiple enlarged iliac and retroperitoneal lymph nodes Event occurrence (as per hospital records): 26 May 2018 at 5:00 p.m. Reporting at hospital: 26 May 2018 at 5:00 p.m. Received first dose of study drug: 2 June 2018 at 12:30 a.m. Surgery/procedure during hospitalization (if any): Laparotomy for ovarian masses with hysterectomy with rectosigmoid endometriotic resection with bladder endometriotic resection done on 1 June 2018 |
| 11-004 |
Male, age 26 years; case of haematemesis for 2 days. Upper GI endoscopy: D1-clean based 1.5 × 0.5 cm ulcer present at D1/D2 junction with surrounding oedematous margins Event occurrence (as per hospital records): 22 July 2018 at 22:23 p.m. Reporting at hospital: 22 July 2018 at 22:23 p.m. Received first dose of study drug: 23 July 2018 at 11:15 a.m. Surgery/procedure during hospitalization (if any): None |
10-006 |
Male, age 58 years; case of fall, fracture of lower end left radius, and fracture of intertrochanteric left femur Event occurrence (as per hospital records): 14 June 2018 at 8:30 a.m. Reporting at hospital: 16 June 2018 at 10:50 a.m. Received first dose of study drug: 16 June 2018 at 3:00 p.m. Surgery/procedure during hospitalization (if any): ORIF with long PFN and SS wire performed on 16 June 2018. K-wire lower end radius left done on 18 June 2018 |
| 11-005 |
Male, age 60 years; case of peptic ulcer, haematemesis, pain in abdomen since 5 months, epigastric pain, diffuse, non-colicky, generalized weakness, melena since 15 days, severely malnourished, pallor++, hypovolemic shock Event occurrence (as per hospital records): 23 July 2018 at 10:11 a.m. Reporting at hospital: 23 July 2018 at 10:11 a.m. Received first dose of study drug: 23 July 2018 at 13:40 a.m. Surgery/procedure during hospitalization (if any): None |
11-002 |
Male, age 63 years; case of peptic ulcer, chief complaint of haematemesis (3–4 episodes) since one day. Pallor++ history of retching, nausea, abdominal pain, and abdominal distension. UGI endoscopy-circumferential ulcer in distal anterior, duodenum-ulcer seen in distal body. D1-multiple superficial ulcer Event occurrence (as per hospital records): 26 June 2018 at 9:27 a.m. Reporting at hospital: 26 June 2018 at 9:27 a.m. Received first dose of study drug: 26 June 2018 at 12:06 p.m. Surgery/procedure during hospitalization (if any): Pyloric catheterization |
| 11-003 |
Female, age 50 years; complaint of abdominal pain, haematemesis (4–5 episodes), malena + syncope, altered sensorium, decrease urine output. Pallor + and hypotension, tender hepatomegaly, spleen palpable, upper GI endoscopy showed large, ulcerated area with sloughed out base Event occurrence (as per hospital records): 19 July 2018 at 5:12 a.m. Reporting at hospital: 19 July 2018 at 5:12 a.m. Received first dose of study drug: 19 July 2018 at 11:05 a.m. Surgery/procedure during hospitalization (if any): None |
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